{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-05-14", "results": { "skip": 0, "limit": 100, "total": 2493 } }, "results": [ { "effective_time": "20130320", "inactive_ingredient": [ "Ingredients : Purified Water, Ethyl Alcohol, Hamammelis Extract, Chamomile Extract, Salicyl Alcohol, Ethhylene Glycol, Propylene Glycol, Dodecyl Benzene Sulfonate, EDTA, Methylparaben, Propylparaben. Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben.Purified Water, Sulfer, Catalase, Aqueous extract of arnica, Glycerin, Cetyl Alcohol, Ceteareth-12, Bromelain, Ultrez 21, Mineral Oil, Ethhylene Glycol, Propylene Glycol, Sodium Ascorbyl Phosphate, Triethanolamine, Ascorbic Acid, Dodecyl Benzene Sulfonate, Peppermint oil, Piperine, Mint Base, EDTA, BHT, BHA, Methylparaben, Propylparaben." ], "purpose": [ "Uses: For the management of acne helps clear up acne blemishes, black heads, helps prevent the development of new acne pimples penetrates pores to reduce the number of acne pimples, white heads and black heads help keep skin clear of new acne pimples, white heads and black heads helps prevent new acne pimples, white heads and black heads from forming help prevent the development of new pimples, white heads and black heads" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help or contact a Poison Control center immediately." ], "warnings": [ "Warnings: For external use only. Do not use if you have sensitive skin and/or are sensitive to [active ingredient] When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time avoid unnecessary sun exposure and use sun screen, Acne Clearing Moisture with SPF 45 skin irritation may occur, characterized by redness, burning, itching, peeling, and possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration Stop use and ask a doctor if irritation becomes severe" ], "spl_product_data_elements": [ "Acne Clearning Treatment Face SULFUR, BENZOYL PEROXIDE, SALICYLIC ACID SULFUR SULFUR BENZOYL PEROXIDE BENZOYL PEROXIDE SALICYLIC ACID SALICYLIC ACID WATER CATALINA ARNICA MONTANA GLYCERIN CETYL ALCOHOL CETEARETH-12 BROMELAINS CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) MINERAL OIL ETHYLENE GLYCOL PROPYLENE GLYCOL SODIUM ASCORBYL PHOSPHATE TROLAMINE ASCORBIC ACID DODECYLBENZENESULFONIC ACID PEPPERMINT OIL PIPERINE MINT EDETIC ACID BUTYLATED HYDROXYTOLUENE METHYLPARABEN PROPYLPARABEN VITAMIN A POMEGRANATE GREEN TEA LEAF" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Three Bottles Acne Clearing Cleanser 240 mL Acne Clearing Tonic 120 mL Acne Clearing Treatment 101 60 mL" ], "package_label_principal_display_panel": [ "Acne Clearing Treatment - FACE labels" ], "indications_and_usage": [ "Directions: Acne Clearing Cleanser Acne Clearing Tonic Acne Clearing Treatment 101" ], "set_id": "0001eaa9-e890-4e94-9d44-47a0f3086a02", "id": "d08e6fbf-9162-47cd-9cf6-74ea24d48214", "active_ingredient": [ "Active Ingredient....................................Purpose Sulphur 5%...............................................Acne medication Benzoyl Peroxide 2.5%...............................Acme medication Salicylic acid 2%........................................Acne medication" ] }, { "effective_time": "20130516", "inactive_ingredient": [ "Inactive ingredients: water, diethyhexyl carbonate, ethylhexyl stearate, cyclopentasiloxane, diisostearoyl polyglyceryl-3 dimer dilinoleate, butylene glycol, microcrystalline wax, prunus amygdalus dulcis (sweet almond) oil, cetyl dimethicone, magnesium sulfate, hydrogentated castor oil, alumina, silica, polyquaternium-7, aminomethyl propanol, phenoxyethanol, cyclohexasiloxane, chlorphenesin, glycerin, methylparaben, benzoic acid, may contain (+/-) titanium dioxide, (ci77891), Iron oxides (ci77491, ci77492, ci77499) iln c81001r" ], "warnings": [ "Warnings: For external use only _______________________________ UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen. _____________________________________ When using this product keep out of eyes. Rinse with water to remove. ____________________________________ Stop use and see a doctor if skin rash occurs ___________________________________ Keep out of reach of children" ], "spl_product_data_elements": [ "Stila Sheer Color Tinted Moisturizer Warm SPF 15 Octinoxate, Avobenzone OCTINOXATE OCTINOXATE AVOBENZONE AVOBENZONE WATER MAGNESIUM SULFATE ALMOND OIL HYDROGENATED CASTOR OIL CYCLOMETHICONE 5 CYCLOMETHICONE 6 TITANIUM DIOXIDE BUTYLENE GLYCOL ALUMINUM OXIDE SILICON DIOXIDE FERROSOFERRIC OXIDE AMINOMETHYLPROPANOL FERRIC OXIDE YELLOW FERRIC OXIDE RED PHENOXYETHANOL CHLORPHENESIN GLYCERIN METHYLPARABEN BENZOIC ACID" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions: Apply with fingers to your face. Blend well" ], "how_supplied": [ "stila cosmetics.com dist. by stila styles, llc los angeles, ca 90027 biorius spri 2 rue rene descartes b-7000 mons, belgium made in u.s.a. S09C" ], "package_label_principal_display_panel": [ "stila SPF15 sheer color tinted moisturizer 1.7 fl. oz. / oz.liq./50ml SCTMSPF15" ], "indications_and_usage": [ "USES: Provides moderate sun protection" ], "set_id": "003d5e05-02b4-46be-901b-59c743e5b841", "id": "e21f12d4-1a7b-4fc6-9542-e5536acf3c5c", "active_ingredient": [ "Active Ingredients: Purpose Octinoxate 7.5% Sunscreen Avobenzone 3.0% Sunscreen" ] }, { "effective_time": "20100601", "inactive_ingredient": [ "Inactive Ingredients: Water (Aqua), SD Alcohol 40, Glycerin, Astragalus Gummifer Gum, Carbomer, Boric Acid, Disodium EDTA, Ethyl Ether, Triethanolamine, Methylparaben, Propylparaben" ], "purpose": [ "Purpose: Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For External Use Only When using this product avoid contact with eyes. Do not use on deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes.", "Directions: Adults and children 2 years of age and older - Cleanse affected area thoroughly. Apply 3-4 times daily. Children under 2 years old - Consult a doctor." ], "questions": [ "Questions or comments? www.BurnBGoneOTC.com" ], "spl_product_data_elements": [ "Burn-B Gone OTC Allantoin Allantoin Allantoin Water Alcohol Glycerin Tragacanth Carbomer Homopolymer Type C Boric Acid Edetate Disodium Ether Trolamine Methylparaben Propylparaben" ], "openfda": {}, "version": "1", "stop_use": [ "Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days." ], "storage_and_handling": [ "Other Information: Store between 15-30C (59-86F)" ], "do_not_use": [ "Do not use on deep or puncture wounds animal bites serious burns" ], "package_label_principal_display_panel": [ "Burn-B_Gone_OTC 75g Tube Artwork" ], "indications_and_usage": [ "Uses: Temporarily protects skin after minor burns scrapes cuts Helps prevent, temporarily protects, and helps relieve chapped or cracked skin. Helps prevent and protect skin from the drying effects of wind and cold weather." ], "set_id": "0061a03b-4886-44ae-a0e1-f0336ee5d2e6", "id": "6e3069bd-e7ef-4f98-a0c7-18b7ce943776", "active_ingredient": [ "Active Ingredient: Allantoin 1.0%" ] }, { "effective_time": "20131004", "inactive_ingredient": [ "Inactive ingredients Water (Aqua), Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Propylene Glycol, Dimethyl Sulfone, Lavandula Angustifolia (Lavendar) Oil, Lidocaine, Aloe Barbadensis Leaf Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Xanthan Gum, Triethanolamine, Methylparaben, Propylparaben, DMDM Hydantoin, Iodopropynyl Butylcarbamate." ], "purpose": [ "Purpose Topical Analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Consult physician for children under 12." ], "warnings": [ "Warnings Only for external use. Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes. Consult your physician: if pain is persistent or worsens or if using any other topical pain products. Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water." ], "spl_product_data_elements": [ "New Terocin Methyl Salicylate, Capsaicin, and Menthol METHYL SALICYLATE SALICYLIC ACID CAPSAICIN CAPSAICIN MENTHOL MENTHOL WATER PROPYLENE GLYCOL CETYL ALCOHOL STEARIC ACID GLYCERYL MONOSTEARATE PEG-100 STEARATE DIMETHYL SULFONE LIDOCAINE LAVENDER OIL ALOE VERA LEAF BORAGE OIL INDIAN FRANKINCENSE XANTHAN GUM TROLAMINE METHYLPARABEN PROPYLPARABEN DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately afterwards to avoid contact with eyes." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel NDC 53217-0004-01 New Terocin Topical Pain Relief Lotion Long Lasting Soothing Effect 120 ml (4 fl oz.) Manufactured for: Alexso Inc. Thousand Oaks, CA 91360 Made in U.S.A. Patent Pending Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Store in a dry, cool place For Comments or Questions, call 888-495-6075 IMAGE LABEL" ], "indications_and_usage": [ "Uses Temporarily relieves mild aches and pains of muscles or joints." ], "set_id": "00b96109-8ece-4531-8182-f5167e9f4632", "id": "2d60485d-d6e7-47d7-813d-0db3a3214e20", "active_ingredient": [ "Active ingredient Methyl Salicylate 25% Capsaicin 0.025% Menthol 10%" ] }, { "effective_time": "20120717", "inactive_ingredient": [ "INACTIVE INGREDIENTS WATER, GLYCERIN, NIACINAMIDE VITAMIN B3, , DIMETHICONE, ISOPROPYL ISOSTEARATE, POLYACRYLAMIDE, TRIETHANOLAMINE, ZINC OXIDE, SODIUM ASCORBYL PHOSPHATE, CAMELLIA SINENSIS LEAF EXTRACT, STEARYL ALCOHOL, C13-14 ISOPARAFFIN, CETYL ALCOHOL, PTFE, PANTHENOL PRO-VITAMIN B5, , TOCOPHERYL ACETATE VITAMIN E , BENZYL ALCOHOL, TITANIUM DIOXIDE, BEHENYL ALCOHOL, DIMETHICONOL, SUCROSE POLYCOTTONSEEDATE, ETHYLPARABEN, CARBOMER, LAURETH-7, METHYLPARABEN, PROPYLPARABEN, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, PEG-100 STEARATE, DISODIUM EDTA, STEARIC ACID, AMMONIUM POLYACRYLATE, BHT, PEG-4, PEG-4 LAURATE, PEG-4 DILAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRIETHOXYCAPRYLYLSILANE." ], "purpose": [ "the result? Visibly younger-looking skin that's better protected against sun damage." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "WARNING FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED. AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR. KEEP OUT OF REACH OF CHILDREN." ], "when_using": [ "FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED. AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER." ], "questions": [ "Questions? 1-800-285-5170 www.olay.com" ], "spl_product_data_elements": [ "Olay Total Effects UV Moisturizer SPF 15 Fragrance Free Octisalate, Avobenzone, Ensulizole, and Octocrylene Octisalate Octisalate Avobenzone Avobenzone Ensulizole Ensulizole Octocrylene Octocrylene WATER GLYCERIN NIACINAMIDE DIMETHICONE TROLAMINE ZINC OXIDE SODIUM ASCORBYL PHOSPHATE GREEN TEA LEAF STEARYL ALCOHOL C13-14 ISOPARAFFIN CETYL ALCOHOL PANTHENOL .ALPHA.-TOCOPHEROL BENZYL ALCOHOL TITANIUM DIOXIDE DOCOSANOL ETHYLPARABEN LAURETH-7 METHYLPARABEN PROPYLPARABEN CETEARYL GLUCOSIDE CETOSTEARYL ALCOHOL EDETATE DISODIUM STEARIC ACID BUTYLATED HYDROXYTOLUENE PEG-4 DILAURATE IODOPROPYNYL BUTYLCARBAMATE TRIETHOXYCAPRYLYLSILANE" ], "ask_doctor": [ "IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "directions Apply liberally before sun exposure on face and neck as often as necessary each day to help protect your skin from harmful UV rays while keeping skin soft and smooth. Gentle enough for everyday use. Designed to replace your moisturizer and specialty skin care products. Children under six months of age: consult a doctor." ], "stop_use": [ "DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR." ], "spl_unclassified_section": [ "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 50 mL Carton OLAY ® total effects ® 7-IN-1 ANTI-AGING UV MOISTURIZER plus SPF 15 | fragrance-free 7 anti-aging therapies in 1 vitamin and anti-oxidant moisturizer +UVA/UVB for visibly younger-looking and protected skin 1.7 FL OZ (50 mL) BROAD SPECTRUM SPF 15 UVA/UVB SUNSCREEN Principal Display Panel - 50 mL Carton" ], "indications_and_usage": [ "how does it work? It provides the total anti-aging power of moisture with vitamins and anti-oxidants plus UVA/UVB (SPF 15) protection to help prevent sun damage. Use the Total Effects system for your anti-aging regimen: Total Effects 7-in-1 Cleansers Total Effects 7-in-1 Boosters" ], "set_id": "00c6d639-6700-4a39-96d5-9865531425d2", "id": "a77cd5ca-875d-4f55-b73e-5025c86b5213", "active_ingredient": [ "ACTIVE INGREDIENTS 4.0% OCTISALATE, 2.0% AVOBENZONE, 1.0% ENSULIZOLE, 1.0% OCTOCRYLENE." ] }, { "effective_time": "20150709", "inactive_ingredient": [ "Inactive ingredients water, cetearyl alcohol, PEG-40 castor oil, dimethicone, polyglyceryl-4 isostearate, cyclomethicone, dea-cetyl phosphate, hexyl laurate, emu oil, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethicone, polysorbate 60, diazolidinyl urea, sodium dehydroacetate, sodium hyaluronate, allantoin, carbomer, methylparaben, magnesium aluminum silicate, sodium ascorbate, propylparaben. may contain: iron oxides, titanium dioxide, mica." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings ​For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or comments? Call ​1-888-637-2437 ​, M - F 9am - 5 pm CST." ], "spl_product_data_elements": [ "Laura Mercier Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen - Tan MERADIMATE,OCTINOXATE MERADIMATE MERADIMATE OCTINOXATE OCTINOXATE WATER CETOSTEARYL ALCOHOL PEG-40 CASTOR OIL DIMETHICONE POLYGLYCERYL-4 ISOSTEARATE CYCLOMETHICONE DIETHANOLAMINE CETYL PHOSPHATE HEXYL LAURATE EMU OIL .ALPHA.-TOCOPHEROL ACETATE POLYSORBATE 60 DIAZOLIDINYL UREA SODIUM DEHYDROACETATE HYALURONATE SODIUM ALLANTOIN METHYLPARABEN MAGNESIUM ALUMINUM SILICATE SODIUM ASCORBATE PROPYLPARABEN FERRIC OXIDE RED TITANIUM DIOXIDE MICA" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours ​Sun Protection Measures. ​ Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Other information Protect the product in this container from excessive heat and direct sun." ], "stop_use": [ "Stop use and ask a doctor if rash occurs." ], "do_not_use": [ "Do not use on damaged or broken skin." ], "package_label_principal_display_panel": [ "Product Labels Tube Carton" ], "indications_and_usage": [ "Uses helps prevent sunburn if used as directed with other sun protection measures (see ​Directions ​ ​), decreases the risk of skin cancer and early skin aging caused by the sun." ], "set_id": "00d026bb-ca19-4598-99b9-b2639dce825c", "id": "d19c02ba-2271-4c92-837f-d6b186be8eb9", "active_ingredient": [ "Active ingredients Meradimate 3.5% Octinoxate 7.5% Purpose Sunscreen" ] }, { "effective_time": "20110111", "inactive_ingredient": [ "INACTIVE INGREDIENT Other Ingredients: Mica, Dimethicon, Nylon-12, Zinc Stearate, Silica, Methicon, Squalane, Magnesium Myristate, Sea Salt/Maris Sal/Sel Marin, Aloe Barbadensis Leaf Jucie, Silk Powder/Serica/Poudre de Soice, Ascorbyl Palmitate, Retinyl Palmitate, Tocopherol, Alumina, Oryza Sative (Rice) Starch, Butylparaben, Methylparaben, Propylparaben, Sodium Dehydroacetate. [May Contain/Peut Contenir (+/-) Bismuth Oxychloride (CI 77163), Carmine (CI 75470), Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).]" ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN Keep out of reach of children." ], "purpose": [ "OTC - PURPOSE Provides SPF 20 sun protection." ], "warnings": [ "WARNINGS WARNING: For extrenal use only. Keep out of eyes. Stop use and see a doctor if rash or irritation develops and lasts." ], "when_using": [ "OTC - WHEN USING Keep out of eyes." ], "spl_product_data_elements": [ "Pure Finish Mineral Powder Foundation SPF 20 Pure Finish 10 Titanium Dioxide TITANIUM DIOXIDE TITANIUM DIOXIDE MICA DIMETHICONE ZINC STEARATE SILICON DIOXIDE SQUALANE MAGNESIUM MYRISTATE SEA SALT STARCH, RICE ALUMINUM OXIDE METHYLPARABEN SODIUM DEHYDROACETATE ALOE VERA LEAF PROPYLPARABEN VITAMIN A PALMITATE ASCORBYL PALMITATE BUTYLPARABEN ALPHA-TOCOPHEROL Pure Finish 10" ], "description": [ "DESCRIPTION For all skin types. Mediun/full coverage. Pure, luminous finish. Pure minerals. Pure comfort. Pure perfection. This microlight mineral makeup is ultra blendable and buildable. SPF 20 sun protection. Fragrance free. Talc free. Oil free. Freshly ground for ultimate purity. Clinically and dermatologist tested. Sensititve skin tested." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Smooth on to face." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Pure Finish Mineral Powder Foundation Carton Pure Finish Mineral Powder Foundation SPF 20 Base Label" ], "indications_and_usage": [ "INDICATIONS AND USAGE To Use: Turn dial to the right to release product. Smooth on to face before sun exposure." ], "set_id": "00d9c5be-ec3e-45f0-85c1-cdc4d07052d9", "id": "b14135f7-f575-4d2b-a719-7875c5f0b6a5", "active_ingredient": [ "OTC - ACTIVE INGREDIENT Active Ingredient: Titanium Dioxide 4.31% w/w." ] }, { "effective_time": "20101206", "inactive_ingredient": [ "Inactive ingredients Aqua (Water), Glycerin, Butylene glycol, C12-15 alkyl benzoate, Cyclopentasiloxane, Glyceryl stearate, Cetyl alcohol, Dimethicone, Petrolatum, Paraffinum liquidum (Mineral oil), Mica, PEG-100 stearate, Cyclohexasiloxane, C18-36 acid glycol ester, Phenoxyethanol, Methylparaben, Sodium stearoyl lactylate, Polyacrylamide, Alumina, C13-14 isoparaffin, Tetrasodium EDTA, Laureth-7, BHT [+/- (May contain) CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides)." ], "purpose": [ "Uses Provides moderate protection against adverse effects of the sun Higher SPF gives more protection." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . If swallowed get medical help." ], "questions": [ "USA: Questions? 1-866-75-BOOTS" ], "spl_product_data_elements": [ "No7 Soft and Sheer Tinted Moisturiser Medium Octinoxate and Titanium Dioxide OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER GLYCERIN BUTYLENE GLYCOL C12-15 ALKYL BENZOATE CYCLOMETHICONE 5 GLYCERYL MONOSTEARATE CETYL ALCOHOL DIMETHICONE PETROLATUM MINERAL OIL POLYOXYL 100 STEARATE CYCLOMETHICONE 6 PHENOXYETHANOL METHYLPARABEN TALC PROPYLPARABEN XANTHAN GUM ALUMINUM OXIDE C13-14 ISOPARAFFIN EDETATE SODIUM BUTYLATED HYDROXYTOLUENE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "description": [ "Nicely natural... Add a little sheer colour while you gently care for your skin, with this soft and silky tinted moisturiser. It hydrates for 12 hours while light-reflecting particles help smooth the appearance of fine lines and flaws for a natural finish all day long. Dermatologically Tested www.boots.com", "Nicely natural... Add a little sheer colour while you gently care for your skin, with this soft and silky tinted moisturiser. It hydrates for 12 hours and evens out your complexion in one simple step, for a natural finish all day long. With light reflecting particles to help smooth the appearance of fine lines and flaws, plus Sunscreen SPF 15 to help protect your skin from the ageing effects of the sun. Ready to face the day... Shake before use. Smooth on evenly, just like your usual moisturiser. Dermatologically Tested." ], "warnings_and_cautions": [ "Warnings For external use only When using this product Avoid contact with eyes. If contact occurs rinse immediately with cold water." ], "ask_doctor": [ "Stop use and ask a doctor if rash or irritation develops and lasts." ], "openfda": {}, "version": "1", "storage_and_handling": [ "Other information Do not store above 30 0 C or 86 0 F" ], "information_for_patients": [ "Mfd in France for BBI Ltd NG2 3AA. UK Dist in the USA by Boots Retail USA Inc. Stamford CT 06901", "www.boots.com Mfd in France for BBI Ltd NG2 3AA. UK Dist in the USA by Boots Retail USA Inc. Stamford CT 06901 USA: Questions? 1-866-75-BOOTS" ], "package_label_principal_display_panel": [ "No7 Soft and Sheer Tinted Moisturiser Moisturises, protects and gives you a natural glow Sunscreen SPF 15 Hypo-allergenic Boots 50ml e 1.69 US Fl. Oz Soft and Sheer Tinted Moisturiser carton.jpg Soft and Sheer Tinted Moisturiser carton", "No7 Soft and Sheet Tinted Moisturiser All Skin types Sunscreen SPF 15 Hypo-allergenic Boots 50ml e 1.69 US Fl. Oz Soft and Sheer Tinted Moisturiser tube.jpg Soft and Sheer Tinted Moisturiser tube" ], "indications_and_usage": [ "Directions Shake before use. Smooth on evenly, just like your usual moisturiser. Apply evenly at least 15 minutes before sun exposure. Reapply as needed. Not intended for children under the age of 12. Not intended for protection while sunbathing." ], "set_id": "00ef44c2-3acf-4d31-93b6-fa6e50699cd5", "id": "4939ae99-6e9f-4b63-adc6-2bec3a92151b", "active_ingredient": [ "Active Ingredients Purpose Octinoxate 5% Sunscreens Titanium Dioxide 1.9%", "Tube label Active Ingredients: Octinoxate 5% Titanium Dioxide 1.9%" ] }, { "effective_time": "20141013", "inactive_ingredient": [ "Inactive ingredients Aloe Barbadensis Leaf Juice, Butylparaben, Citric Acid, Diazolidinyl Urea, Disodium Cocoamphodiacetate, Ethylparaben, Glycerin, Isobutylparaben, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, Tocopheryl Acetate, Water" ], "purpose": [ "Purpose Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep this and all drugs out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "WARNINGS When using this product avoid contact with eyes; not to be applied over deep or puncture wounds or lacerations For external use only Keep this and all drugs out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately. Consult a doctor: if condition worsens or does not improve within 7 days." ], "when_using": [ "When using this product avoid contact with eyes; not to be applied over deep or puncture wounds or lacerations For external use only" ], "spl_product_data_elements": [ "Baza Cleanse and Protect DIMETHICONE DIMETHICONE DIMETHICONE ALOE VERA LEAF BUTYLPARABEN CITRIC ACID MONOHYDRATE DIAZOLIDINYL UREA DISODIUM COCOAMPHODIACETATE ETHYLPARABEN GLYCERIN ISOBUTYLPARABEN METHYLPARABEN PHENOXYETHANOL POLYSORBATE 20 PROPYLENE GLYCOL PROPYLPARABEN WATER" ], "ask_doctor": [ "Consult a doctor: if condition worsens or does not improve within 7 days." ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions Remove the stool with underpad or Dimethicone cloth Thoroughly cleanse the perineal area using a new Dimethicone cloth. Dispose of soiled cloth in waste receptacle Remove wet and soiled garments promptly; wipe affected area as often as necessary. Use a new Dimethicone cloth with each garment change." ], "spl_unclassified_section": [ "Drug Facts", "Caution Gloves diminish sensitivity to heat Do not use excessively hot cloth Closely monitor heat level with infants, unresponsive, and skin sensitive individuals.", "Cloth Material Polyester rayon", "Distributed by: Coloplast Corp. 1601 W River Rd N, Minneapolis, MN 55411" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 8 Cloth Packet NDC 11701-628-08 Baza Cleanse & Protect ® Cloth with Dimethicone Skin Protectant All-In-One Perineal Cloth With Dimethicone Helps To Prevent Incontinence-Associated Dermatitis CHG compatible Coloplast Product #67088 Contents: 8 Disposable Cloths A14-1963 Open Here Principal Display Panel - 8 Cloth Packet" ], "indications_and_usage": [ "Uses Temporarily protects the skin and helps relieve minor skin irritation due to incontinence-associated dermatitis. Helps seal out wetness." ], "set_id": "010235b4-228e-499e-abf4-29d0ca8696f8", "id": "bc0f02be-774d-4746-9cc2-3f2b4ac67f03", "active_ingredient": [ "Active ingredient Dimethicone, 3%" ] }, { "effective_time": "20130506", "inactive_ingredient": [ "Inactive Ingredients water, glycerin, polyethylene, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 60, dimethicone, cetyl alcohol, cetearyl alcohol, cetearyl glucoside, panthenol (pro-vitamin B5), niacinamide, phenoxythanol, methylparaben, ethylparaben, propylparaben, stearyl alcohol, cyclopentasiloxane, dimethiconol, behenyl alcohol, tocopheryl acetate (vitamin E), DMDM hydantoin, benzyl alcohol, PEG-4 dilaurate, stearic acid, PEG-100 stearate, fragrance, disodium EDTA" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "ShopKo Absolute Daily Moisturizing Broad Spectrum SPF15 Sunscreen Avobenzone, Homosalate, Octinoxate, Octocrylene AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE WATER GLYCERIN HIGH DENSITY POLYETHYLENE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) ISOHEXADECANE POLYSORBATE 60 DIMETHICONE CETYL ALCOHOL CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE PANTHENOL NIACINAMIDE PHENOXYETHANOL METHYLPARABEN ETHYLPARABEN PROPYLPARABEN STEARYL ALCOHOL CYCLOMETHICONE 5 DIMETHICONOL (100000 CST) DOCOSANOL .ALPHA.-TOCOPHEROL ACETATE DMDM HYDANTOIN BENZYL ALCOHOL PEG-4 DILAURATE STEARIC ACID PEG-100 STEARATE EDETATE DISODIUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply liberally 15 minutes before sun exposure. Children under 6 months of age: ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses" ], "stop_use": [ "Stop use and ask a doctor if rash occurs." ], "spl_unclassified_section": [ "Other Information protect the product in this container from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel - Carton Label Shopko* *Compare to Olay ® Complete All Day UV Moisturizer SPF15 Normal Skin Ingredients SPF 15 Daily Moisturizer For Normal Skin Light, Non-Greasy With Vitamin E & Pro-Vitamin B5 Dermatologically Tested Non-Comedogenic (won't clog pores) 100% Oil-Free 100% PABA-Free Absolute Daily Moisturizer provides broad spectrum protection, moisture and vitamins, for beautiful, health-looking skin. Daily broad spectrum protection. Contains Pro-Vitamin B5 for moisturization and long-lasting hydration. Antioxidant vitamins C & E promotes and maintains healthy-looking skin. Lightweight and non-greasy. DIRECTIONS FOR USE: Every day, apply liberally on face and neck, as often as necessary. *This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Olay ® Complete 4 FL OZ (118 mL) Distributed by ShopKo Stores Operating Co., LLC Green Bay, WI 54307 © 2013 ShopKo Stores Operating Co., LLC Made in Israel. www.shopko.com 1D626 8C C1 Carton Label Shopko Daily Moisturizer Label" ], "indications_and_usage": [ "Uses helps prevent sunburn If used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "0111e51d-63c3-43a6-8c55-9f7b96315a3c", "id": "0111e51d-63c3-43a6-8c55-9f7b96315a3c", "active_ingredient": [ "Active ingredient Avobenzone 3.0% Homosalate 3.0% Oclisalate 5.0% Octocrylene 2.6%" ] }, { "effective_time": "20121029", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane, Aqua (Water) Isononyl isononanoate, Glycerin, Silica, Pheny trimethicone, Mica, Dimethicone, Arachidyl propionate, Talc, Titanium dioxide, Disteardimonium hectorite, PEG/PPG-10/1 dimethicone, Alcohol denat., Tocopheryl acetate, Hexyl laurate, Polyglyceryl-4 isostearate, Propylene carbonate, Methylparaben, Ethylparaben, Retinyl palmitate, Ascorbyl glucoside, Lupinus albus seed extract, Carbomer, Dimethylmethoxychromanol, Tetasodium EDTA, Phyllanthus emblica fruit extract, Polysorbate 20, Potasium hyroxide, Ginkgo biloba leaf extract, BHT, Ethylhexylglycerin, Tocopherol, Palmitoyl oligopeptide, Palmitoyl Tetrapeptide-7. May contain CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides)." ], "purpose": [ "Uses Uses - helps prevent sunburn. if used with as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Centre right away." ], "spl_product_data_elements": [ "No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Cool Beige OCTINOXATE OCTINOXATE OCTINOXATE CYCLOMETHICONE 5 WATER ISONONYL ISONONANOATE GLYCERIN SILICON PHENYL TRIMETHICONE MICA DIMETHICONE ARACHIDYL PROPIONATE TALC TITANIUM DIOXIDE PEG/PPG-18/18 DIMETHICONE MAGNESIUM SULFATE PHENOXYETHANOL TRIETHOXYCAPRYLYLSILANE BUTYLENE GLYCOL CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) .ALPHA.-TOCOPHEROL ACETATE HEXYL LAURATE POLYGLYCERYL-4 ISOSTEARATE PROPYLENE CARBONATE METHYLPARABEN ETHYLPARABEN VITAMIN A PALMITATE ASCORBYL GLUCOSIDE LUPINUS ALBUS SEED CARBOMER HOMOPOLYMER TYPE C EDETATE SODIUM TETRAHYDRATE PHYLLANTHUS EMBLICA FRUIT JUICE POLYSORBATE 20 POTASSIUM HYDROXIDE GINKGO BILOBA LEAF OIL BUTYLATED HYDROXYTOLUENE TOCOPHEROL PALMITOYL OLIGOPEPTIDE PALMITOYL TETRAPEPTIDE-7 TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "description": [ "Description Renewed radiance. Gain the immediate appearance of complexion perfection with our light diffusing formula that evens out skin tone. Minimises the appearance of fine lines for younger looking skin. Our Pro-retinol complex containing Lipopeptides boosts and maintain elasticity. Our powerful antioxidant complex and SPF 15 help protect against the ageing effects of free radicals. For Best Results: Shake before use. Blend smoothly and evenly with your fingers or a sponge, working downwards and outwards from the centre of your face. Do not store above 30 degrees C or 86 degrees F. Hypo-allergenic: Because all skin can have sensitive moments all our foundation products are hypo-allergenic so they are kind to even the most sensitive skin.", "Description Smoothes and moisturises for younger looking skin and a flawless, radiant complexion. For Best Results: Shake before use. Blend on smoothly and evenly with your fingers or a sponge." ], "warnings_and_cautions": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove", "Warnings Avoid contact with eyes. If product gets into the eyes, rinse well with water immediately." ], "ask_doctor": [ "Ask a doctor Stop use and ask a doctor if rash occurs." ], "openfda": {}, "version": "1", "storage_and_handling": [ "Storage Other information - protect the product in this container from excessive heat and direct sun" ], "information_for_patients": [ "INFORMATION The Boots Company PLC Nottingham England NG3 3AA Dist by Boots Retail USA Inc Norwalk CT 06851 USA Made in France www.boots.com .", "The Boots Company PLC Nottingham England NG2 3AA Dis by Boots Retail USA InC Norwalk CT 06851 USA Made in France www.boots.com ." ], "package_label_principal_display_panel": [ "carton label carton label1 carton label 1" ], "indications_and_usage": [ "Directions Directions apply liberally 15 minutes bfore sun exposure reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses" ], "set_id": "01529f45-8bbe-453a-8421-6d104d36baa5", "id": "0e00ba2f-71f5-473a-b930-4dd5a256800a", "active_ingredient": [ "Carton active ingredient section Active ingredients Octinoxate 5% Purpose sunscreen.", "Bottle label No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Younger looking skin Hypo-allergenic 30ml 1 US Fl Oz Active ingredients Octinoxate 5%." ] }, { "effective_time": "20141014", "inactive_ingredient": [ "INGREDIENTS WATER (AQUA), SQUALANE, OCTYLDODECYL MYRISTATE, DIPROPYLENE GLYCOL, ETHYLHEXYL METHOXYCINNAMATE, CETYL ALCOHOL, GLYCERYL STEARATE SE, HYDROGENATED CASTOR OIL ISOSTEARATE, NIACINAMIDE, PEG-2 STEARATE, PHYTOSTERYL MACADAMIATE, SODIUM CETYL SULFATE, BEESWAX (CERA ALBA), DIMETHICONE, GLYCERYL STEARATE, CHOLESTEROL, DIPOTASSIUM GLYCYRRHIZATE, GLYCERIN, METHYLSERINE, PRUNUS ARMENIACA (APRICOT) JUICE, BUTYLENE GLYCOL, DISODIUM EDTA, FRAGRANCE (PARFUM), ALCOHOL, DIMETHOXY DI-p-CRESOL, PYRACANTHA FORTUNEANA FRUIT EXTRACT, HYDROLYZED SILK, BHT, BLETILLA STRIATA ROOT EXTRACT, PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, ALPHAISOMETHYL IONONE, CITRONELLOL, HEXYL CINNAMAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, RED 4 (CI 14700), YELLOW 5 (CI 19140)" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "purpose": [ "OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE) 3% Sunscreen" ], "warnings": [ "Warning Stop use and ask a doctor if skin rash occurs. Keep out of reach of children." ], "spl_product_data_elements": [ "SENSAI CELLULAR PERFORMANCE INTENSIVE HAND TREATMENT OCTINOXATE OCTINOXATE OCTINOXATE WATER SQUALANE DIPROPYLENE GLYCOL CETYL ALCOHOL NIACINAMIDE SODIUM CETYL SULFATE YELLOW WAX DIMETHICONE GLYCERYL MONOSTEARATE CHOLESTEROL GLYCYRRHIZINATE DIPOTASSIUM GLYCERIN APRICOT BUTYLENE GLYCOL EDETATE DISODIUM ALCOHOL BUTYLATED HYDROXYTOLUENE PRUNUS ARMENIACA SEED METHYLPARABEN ETHYLPARABEN PROPYLPARABEN BUTYLPARABEN .BETA.-CITRONELLOL, (R)- LINALOOL, (+/-)- FD&C RED NO. 4 FD&C YELLOW NO. 5" ], "openfda": {}, "version": "4", "stop_use": [ "Stop use and ask a doctor if skin rash occurs." ], "spl_unclassified_section": [ "DIST.: KANEBO COSMETICS USA LLC 330 Madison Avenue, New York, NY 10017" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton SENSAI CELLULAR PERFORMANCE SPF 8 INTENSIVE HAND TREATMENT Kanebo INTERNATIONAL NET WT. 3.5 OZ. 100mL e Principal Display Panel" ], "indications_and_usage": [ "Direction Apply liberally and evenly before sun exposure and as needed. Use helps prevent sunburn. Apply and reapply as directed to avoid lowering protection." ], "set_id": "016195b1-3439-4b4d-8cb2-2c70f65b27e2", "id": "d120365e-09a7-4e0a-8cb6-f5137da3808c", "active_ingredient": [ "ACTIVE INGREDIENTS OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE) 3% Sunscreen" ] }, { "effective_time": "20101102", "inactive_ingredient": [ "Other Ingredients .Methylparaben Potassium Sorbate (natural preservative ). Propylparaben , Viracea (proprietary Echinacea purpurea extract), water (purified)" ], "purpose": [ "USES: For the relive of symtoms associated with shingles including pain, Burning, Itching and tingling First aid to help guard against secondary skin infection due to shingles." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN: If swallow get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS: For external used only. Not for ingestion. Do not used - in yeast infections- do not spray directly on the eyes When using this product , may tingle on contact. Stop used and ask doctor if - condition worsens- symptoms last more then 7 days ." ], "spl_product_data_elements": [ "shing-Releev Benzalkonium Chloride Benzalkonium Chloride Benzalkonium Water Methylparaben Potassium Sorbate Propylparaben Echinacea purpurea flowering top Allantoin Allantoin Benzyl Alcohol Benzyl Alcohol" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Apply to area as needed 3-4 times daily. Do not use cotton applicator. May be used with sterile bandage after area is dry." ], "package_label_principal_display_panel": [ "Shing Carton approved.jpg Shing Carton approved" ], "indications_and_usage": [ "DIRECTIONS: Use at first sign of irritation or itching. Adults and children 12 years or older. Clean without soap. apply liberally to clean dry area free of soap or cleanser residue." ], "set_id": "016c9977-9803-4830-be48-222bdc0e24fd", "id": "20dbda91-9eaa-4045-8413-32db362f1644", "active_ingredient": [ "ACTIVE INGREDIENTS: Benzalkanium Chloride .13% Allantoin .5% Benzyl Alcohol .5%" ] }, { "effective_time": "20140609", "inactive_ingredient": [ "Talc, Mica(CI 77019), Silica(CI 77811), Hexyl Laurate, Dimethicone, Diisostearyl Malate, Mineral Oil, Phenyl Trimethicone, Squalane, Iron Oxides(CI 77492), Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol Stearate, Fragrance, Iron Oxides(CI 77491), Ultramarines(CI 77007), Methylparaben, Iron Oxides(CI 77499), Propylparaben, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Silk, Tocopheryl Acetate, Macadamia Integrifolia Seed Oil" ], "instructions_for_use": [ "After applying make-up base or liquid foundation, put appropriate amount on a puff and tap lightly on face for even application." ], "warnings": [ "Avoid application to wounded or infected area. Do NOT use if irritation develops. If so, consult a physician immediately. Keep out of reach of children. Cover lid after each use. Store at a cool, dry place, away from direct sunlight. Instantly rinse with cold water when product comes in contact with eye(s)." ], "spl_product_data_elements": [ "Impact Fix Prism Two Way Cake SPF 24, No. 33 Titanium Dioxide, Zinc Oxide, Octinoxate TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION OCTINOXATE OCTINOXATE TALC MICA SILICON DIOXIDE HEXYL LAURATE FERRIC OXIDE YELLOW DIMETHICONE MINERAL OIL DIISOSTEARYL MALATE PHENYL TRIMETHICONE SQUALANE FERROSOFERRIC OXIDE LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER METHICONE (20 CST) FERRIC OXIDE RED DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) METHYLPARABEN PROPYLPARABEN JOJOBA OIL ALPHA-TOCOPHEROL ACETATE MACADAMIA OIL" ], "other_safety_information": [ "Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating." ], "openfda": {}, "version": "2", "package_label_principal_display_panel": [ "Package & product & refill front image Package & product & refill back image" ], "indications_and_usage": [ "Not only will it help prevent sunburn, it also reduces the risk of skin cancer and early skin aging if used as directed with other sun protection measures. (SPF value of 15 or higher)" ], "set_id": "016e4800-3ee2-47cd-8859-4e4a70a13ac2", "id": "a6a996bd-3f31-4ed8-a168-ebbb70804b9e" }, { "effective_time": "20121030", "inactive_ingredient": [ "Inactive ingredients Cyclopentasiloxane, Aqua (Water) Isononyl isononanoate, Glycerin, Silica, Pheny trimethicone, Mica, Dimethicone, Arachidyl propionate, Talc, Titanium dioxide, Disteardimonium hectorite, PEG/PPG-10/1 dimethicone, Alcohol denat., Tocopheryl acetate, Hexyl laurate, Polyglyceryl-4 isostearate, Propylene carbonate, Methylparaben, Ethylparaben, Retinyl palmitate, Ascorbyl glucoside, Lupinus albus seed extract, Carbomer, Dimethylmethoxychromanol, Tetasodium EDTA, Phyllanthus emblica fruit extract, Polysorbate 20, Potasium hyroxide, Ginkgo biloba leaf extract, BHT, Ethylhexylglycerin, Tocopherol, Palmitoyl oligopeptide, Palmitoyl Tetrapeptide-7. May contain CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides)." ], "purpose": [ "Uses Uses - helps prevent sunburn. if used with as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Centre right away." ], "spl_product_data_elements": [ "No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Mocha OCTINOXATE OCTINOXATE OCTINOXATE CYCLOMETHICONE 5 WATER ISONONYL ISONONANOATE GLYCERIN SILICON PHENYL TRIMETHICONE MICA DIMETHICONE ARACHIDYL PROPIONATE TALC TITANIUM DIOXIDE PEG/PPG-18/18 DIMETHICONE MAGNESIUM SULFATE PHENOXYETHANOL TRIETHOXYCAPRYLYLSILANE BUTYLENE GLYCOL CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) .ALPHA.-TOCOPHEROL ACETATE HEXYL LAURATE POLYGLYCERYL-4 ISOSTEARATE PROPYLENE CARBONATE METHYLPARABEN ETHYLPARABEN VITAMIN A PALMITATE ASCORBYL GLUCOSIDE LUPINUS ALBUS SEED CARBOMER HOMOPOLYMER TYPE C EDETATE SODIUM TETRAHYDRATE PHYLLANTHUS EMBLICA FRUIT JUICE POLYSORBATE 20 POTASSIUM HYDROXIDE GINKGO BILOBA LEAF OIL BUTYLATED HYDROXYTOLUENE TOCOPHEROL PALMITOYL OLIGOPEPTIDE PALMITOYL TETRAPEPTIDE-7 TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "description": [ "Description Renewed radiance. Gain the immediate appearance of complexion perfection with our light diffusing formula that evens out skin tone. Minimises the appearance of fine lines for younger looking skin. Our Pro-retinol complex containing Lipopeptides boosts and maintain elasticity. Our powerful antioxidant complex and SPF 15 help protect against the ageing effects of free radicals. For Best Results: Shake before use. Blend smoothly and evenly with your fingers or a sponge, working downwards and outwards from the centre of your face. Do not store above 30 degrees C or 86 degrees F. Hypo-allergenic: Because all skin can have sensitive moments all our foundation products are hypo-allergenic so they are kind to even the most sensitive skin.", "Description Smoothes and moisturises for younger looking skin and a flawless, radiant complexion. For Best Results: Shake before use. Blend on smoothly and evenly with your fingers or a sponge." ], "warnings_and_cautions": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove", "Warnings Avoid contact with eyes. If product gets into the eyes, rinse well with water immediately." ], "ask_doctor": [ "Ask a doctor Stop use and ask a doctor if rash occurs." ], "openfda": {}, "version": "2", "storage_and_handling": [ "Storage Other information - protect the product in this container from excessive heat and direct sun" ], "information_for_patients": [ "INFORMATION The Boots Company PLC Nottingham England NG3 3AA Dist by Boots Retail USA Inc Norwalk CT 06851 USA Made in France www.boots.com .", "The Boots Company PLC Nottingham England NG2 3AA Dist by Boots Retail USA InC Norwalk CT 06851 USA Made in France www.boots.com ." ], "package_label_principal_display_panel": [ "carton label carton label1 carton label 1" ], "indications_and_usage": [ "Directions Directions apply liberally 15 minutes bfore sun exposure reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses" ], "set_id": "01ad8667-972c-4281-97ad-b087c7e58ab6", "id": "79d6ee52-b386-4732-bbcc-217545c33311", "active_ingredient": [ "Carton active ingredient section Active ingredients Octinoxate 5% Purpose sunscreen.", "Bottle label No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Younger looking skin Hypo-allergenic 30ml 1 US Fl Oz Active ingredients Octinoxate 5%." ] }, { "effective_time": "20101212", "inactive_ingredient": [ "Inactive ingredients Aqua (Water), Cyclopentasiloxane, Talc, Mica, Ethylhexyl stearate, Cyclohexasiloxane, Dimethicone, Silica, Butylene glycol, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium hectorite, Hexyl laurate, Polyglyceryl-4 isostearate, Dimethicone copolyol, Magnesium sulfate, Phenoxyethanol, Propylene carbonate, Methylparaben, Sodium ascorbyl phosphate, Sodium PCA, Aluminum stearate, Alumina, Tocopheryl acetate, Propylene glycol, Glycerin, Triethoxycaprylylsilane, Sodium lauroyl lactylate, Isopropyl palmitate, Butylparaben, Ethylparaben, Lecithin, Tetrasodium EDTA, Propylparaben, Isobutylparaben, Panax ginseng root extract, Ceramide 3, BHT, Ceramide 6 II, Cholesterol, Phytosphingosine, Morus alba leaf extract, Carbomer, Xanthan gum, Ceramide 1, [+/1 (May contain) CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides)." ], "purpose": [ "Uses Provides moderate protection against adverse effects of the sun Higher SPF gives more protection" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help." ], "questions": [ "Questions? 1-866-75-BOOTS" ], "spl_product_data_elements": [ "No7 Stay Perfect Foundation Sunscreen SPF 15 60 Octinoxate and Titanium Dioxide OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER CYCLOMETHICONE 5 TALC CYCLOMETHICONE 6 DIMETHICONE SILICON DIOXIDE BUTYLENE GLYCOL HEXYL LAURATE POLYGLYCERYL-4 ISOSTEARATE MAGNESIUM SULFATE, UNSPECIFIED PHENOXYETHANOL PROPYLENE CARBONATE METHYLPARABEN SODIUM ASCORBYL PHOSPHATE SODIUM PYRROLIDONE CARBOXYLATE ALUMINUM STEARATE ALUMINUM OXIDE .ALPHA.-TOCOPHEROL ACETATE, DL- PROPYLENE GLYCOL GLYCERIN OCTYLTRIETHOXYSILANE ISOPROPYL PALMITATE BUTYLPARABEN ETHYLPARABEN LECITHIN, SOYBEAN EDETATE SODIUM PROPYLPARABEN ISOBUTYLPARABEN ASIAN GINSENG BUTYLATED HYDROXYTOLUENE CHOLESTEROL WHITE MULBERRY CARBOMER HOMOPOLYMER TYPE C XANTHAN GUM FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "description": [ "Staying power... Discover picture-perfect skin from morning till night, with this stay perfect moisturising foundation. Soft, silky and flattering in any light, it's rub resistant and won't let you down. Fragrance free and easy to blend without blocking your pores. Ready to face the day... Shake before use. Dot onto your face and blend smoothly and evenly with your fingers or a sponge, working downwards and outwards from the centre of your face. Non-pore blocking.", "Discover picture-perfect skin from morning till night, with this stay perfect moisturising foundation. Soft, silky and flattering in any light, its rub resistant and won't let you down. Shake well before use. Blend on smoothly and evenly with your fingers or a sponge. Non-pore blocking." ], "warnings_and_cautions": [ "Warnings For external use only When using this product Keep out of eyes. Rinse with water to remove." ], "ask_doctor": [ "Stop use and ask a doctor if rash or irritation develops and lasts" ], "openfda": {}, "version": "1", "storage_and_handling": [ "Other information Do not store above 30 o C or 86 o F" ], "information_for_patients": [ "www.boots.com Mfd in France for BBI NG2 3AA. UK Dist in the USA by Boots Retail USA Inc Stamford CT 06901", "www.boots.com Mfd in France for BBI Ltd NG2 3AA. UK Dist in the USA by Boots Retail USA Inc. Stamford CT 06901 USA: Questions? 1-866-75-BOOTS" ], "package_label_principal_display_panel": [ "No7 Stay Perfect Foundation For a long-lasting, flawless finish Sunscreen SPF 15 Hypo-allergenic Boots 30ml e 1 US Fl. Oz. Stay Perfect Fdn carton.jpg Stay Perfect Fdn carton", "Stay Perfect Foundation Sunscreen SPF 15 Hypo-allergenic Boots 30ml e 1 US Fl. Oz. Stay Perfect Fdn bottle labels.jpg Stay Perfect Fdn bottle labels" ], "indications_and_usage": [ "Directions Use as a normal foundation Apply evenly at least 15 minutes before sun exposure Reapply as needed Not intended for children under the age of 12 Not intended for protection while sunbathing" ], "set_id": "01e35496-a08d-468e-b6ca-2a0aee890cfd", "id": "c9bcc538-a9b6-42f4-aa1d-e9a6caffbf1c", "active_ingredient": [ "No7 Stay Perfect Foundation Sunscreen SPF 15 Mocha Active Ingredients Purpose Octinoxate 5% Sunscreens Titanium Dioxide 1.6%", "Bottle label Active Ingredients: Octinoxate 5% Titanium Dioxide 1.6%" ] }, { "effective_time": "20130630", "inactive_ingredient": [ "Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax" ], "purpose": [ "Uses helps relieve the local itching and discomfort associated with hemorrhoids temporarily shrinks hemorrhoidal tissue and relieves burning temporarily provides a coating for relief of anorectal discomforts temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external and/or intrarectal use only" ], "when_using": [ "When using this product do not use more than the recommended daily dosage" ], "spl_product_data_elements": [ "Shopko Hemorrhoidal Mineral Oil MINERAL OIL MINERAL OIL PETROLATUM PETROLATUM PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GLYCERIN LANOLIN METHYLPARABEN PROPYLPARABEN STEARYL ALCOHOL THYME OIL ALPHA-TOCOPHEROL ACETATE WATER WHITE WAX" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Distributed By United Exchange Corp 17211 Valley View Ave Cerritos, CA 90703 Made in Korea" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a physician before use." ], "stop_use": [ "Stop use and ask a doctor if bleeding occurs condition gets worse or does not get better within 7 days introduction of the applicator into the rectum causes additional pain" ], "storage_and_handling": [ "Other information store at 20° to 25°C (68° to 77°F)" ], "package_label_principal_display_panel": [ "image of carton label" ], "indications_and_usage": [ "Directions children under 12 years of age: ask a doctor adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe gently dry by patting or blotting with a tissue or a soft cloth before applying when first opening tube, remove foil seal for intrarectal use: remove protective cover from applicator and attach to tube lubricate applicator well, then gently insert applicator into the rectum thoroughly clean applicator and replace protective cover after each use apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement also apply ointment to external area" ], "set_id": "01f99bcc-171d-466e-a636-40ed294e9b72", "id": "7c49c02b-3d97-4de7-8dc3-45b8a493a40c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are now taking a prescription drug for high blood pressure or depression" ], "active_ingredient": [ "Active ingredients Purpose Mineral Oil 14%........................................................Protectant Petrolatum 74.9%.....................................................Protectant Phenylephrine HCl 0.25%...................................Vasoconstrictor" ] }, { "effective_time": "20130711", "inactive_ingredient": [ "Inactive ingredients Water, C12-15 Alkyl Benzoate, Dimethicone, Glycine Soja (Soybean) Seed Extract, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Glycerin, Ethylene/Acrylic Acid Copolymer, Phenoxyethanol, Phenyl Trimethicone, Silica, Panthenol, Arachidyl Alcohol, Aluminum Starch Octenylsuccinate, Cetearyl Glucoside, Methylparaben, Steareth-2, Polyacrylate-13, Behenyl Alcohol, Steareth-21, Polymethyl Methacrylate, Disodium EDTA, Arachidyl Glucoside, Polyisobutene, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Propylparaben, Tocopheryl Acetate, Ethylparaben, Benzalkonium Chloride, Polysorbate 20, PEG-16 Soy Sterol, Sodium Ascorbyl Phosphate, Butylene Glycol, Fragrance, Sodium Hydroxide, Glycine Soja (Soybean) Protein, Mica, Titanium Dioxide" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away" ], "warnings": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away" ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions/Comments 1-800-321-4576" ], "spl_product_data_elements": [ "Ambi Even and Clear Daily Moisturizer Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone Avobenzone Avobenzone Homosalate Homosalate Octisalate Octisalate Octocrylene Octocrylene Oxybenzone Oxybenzone Water Alkyl (C12-15) Benzoate Dimethicone Soybean Cetostearyl Alcohol Diethylhexyl 2,6-Naphthalate Glycerin Phenoxyethanol Phenyl Trimethicone Silicon Dioxide Panthenol Arachidyl Alcohol Aluminum Starch Octenylsuccinate Cetearyl Glucoside Methylparaben Steareth-2 Docosanol Steareth-21 Edetate Disodium Arachidyl Glucoside Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) Propylparaben .Alpha.-Tocopherol Acetate Ethylparaben Benzalkonium Chloride Polysorbate 20 Sodium Ascorbyl Phosphate BUTYLENE GLYCOL Sodium Hydroxide Mica Titanium Dioxide" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • apply generously 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: Ask a doctor" ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "storage_and_handling": [ "Other Information • protect this product from excessive heat and direct sun • may stain some fabrics" ], "do_not_use": [ "For external use only Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 88 mL Bottle Carton AMBI ® SKINCARE EVEN & CLEAR ® 3 fl. oz. (88 mL) PRINCIPAL DISPLAY PANEL - 88 mL Bottle Carton" ], "indications_and_usage": [ "Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "02186c90-33ec-4e44-9e6e-fca39cac9269", "id": "bccd0cbe-5d02-4930-987b-d080c1a65ebd", "active_ingredient": [ "Active ingredients Avobenzone (3%), Homosalate (12%), Octisalate (5%), Octocrylene (1.7%), Oxybenzone (3%)" ] }, { "effective_time": "20100202", "inactive_ingredient": [ "Inactive ingredients: Citric acid, Glycerin, Glycerol sterate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium citrate, Titanium dioxide, Water (purified)" ], "purpose": [ "Uses: For temporary relief of; minor skin irritations Itching and rashes due to; eczema insect bites poison ivy poison oak poison sumac soaps detergents cosmetics jewelry and for external itching of; genital feminine and anal itching" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For external use only" ], "spl_product_data_elements": [ "Hydrocortisone Hydrocortisone Acetate HYDROCORTISONE ACETATE HYDROCORTISONE CITRIC ACID MONOHYDRATE GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN PETROLATUM POLYSORBATE 80 PROPYLENE GLYCOL SODIUM CITRATE TITANIUM DIOXIDE WATER" ], "openfda": {}, "version": "1", "stop_use": [ "Stop use and ask a physician if: the condition persists or gets worse symptoms clear up and occur again within a few days you are pregnant or breast feeding" ], "spl_unclassified_section": [ "Directions: Adults and children over 2 years of age Apply evenly to affected area no more than 3 or 4 times daily. Children under 2 years of age Do not use consult a physician Adults When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly Gently dry, patting and blotting with bathroom tissue or soft cloth before applying apply externally to the area up to 6 times daily or after each bowel movement", "Other information: Store at 20 deg - 25 deg C (68 deg - 77 deg F) Avoid excessive heat and humidity" ], "do_not_use": [ "Do not use: in the eyes longer than 1 week unless directed by a physician for diaper rash if you have vaginal discharge more than the recommended daily dosage unless directed by a doctor in the rectum bu using fingers or any other mechanical device or applicator" ], "package_label_principal_display_panel": [ "Principal Display Panel Hydrocortisone Cream 1% Hydrocortisone" ], "set_id": "0249c123-f4a2-4593-b81c-7295175ad6cb", "id": "d268b744-00fa-42e1-9275-ee17990c70f6", "active_ingredient": [ "Active Ingredient Purpose Hydrocortisone Acetate 1% Antipruritic (anti-itch)" ] }, { "effective_time": "20100810", "inactive_ingredient": [ "Inactive ingredients Aqua (water), glycine soja (soybean) protein, propylene glycol, cyclopentasiloxane, cetyl alcohol, c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, triethanolamine, glyceryl stearate, mannitol, corn starch modified, polyacrylamide, phenoxyethanol, stearic acid, hydrolyzed adansonia digitata extract, peg-75 stearate, methylparaben, c13- 14 isoparaffin, propylparaben, xanthan gum, parfum (fragance), ceteth-20, steareth-20, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylates/c10-30 alkyl acrylate crosspolymer, disodium edta, laureth-7, cyclodextrin, dimethicone crosspolymer, faex extract (yeast extract), dimethicone, hydrolyzed algin, butylparaben, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, laureth-23, laureth-4, disodium succinate, ci42090 (blue 1)." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "LBel Paris Regression Jour Avobenzone, Ensulizole, Octinoxate, and Oxybenzone Avobenzone Avobenzone Ensulizole Ensulizole Octinoxate Octinoxate Oxybenzone Oxybenzone water soybean propylene glycol cyclomethicone 5 cetyl alcohol c12-15 alkyl benzoate snow pea cyclomethicone 6 trolamine glyceryl monostearate mannitol phenoxyethanol stearic acid methylparaben c13-14 isoparaffin propylparaben xanthan gum ceteth-20 steareth-20 edetate disodium laureth-7 yeast dimethicone butylparaben ethylparaben isobutylparaben laureth-23 laureth-4 sodium succinate anhydrous LBel Paris Regression Jour Avobenzone, Ensulizole, Octinoxate, and Oxybenzone Avobenzone Avobenzone Ensulizole Ensulizole Octinoxate Octinoxate Oxybenzone Oxybenzone water soybean propylene glycol cyclomethicone 5 cetyl alcohol c12-15 alkyl benzoate snow pea cyclomethicone 6 trolamine glyceryl monostearate mannitol phenoxyethanol stearic acid methylparaben c13-14 isoparaffin propylparaben xanthan gum ceteth-20 steareth-20 edetate disodium laureth-7 yeast dimethicone butylparaben ethylparaben isobutylparaben laureth-23 laureth-4 sodium succinate anhydrous" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply smoothly every morning before sun exposure and as needed. apply after cleansing and toning on face and neck. children under 6 months of age: ask a doctor." ], "spl_unclassified_section": [ "Drug Facts", "Other information Moderate sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun." ], "stop_use": [ "Stop use and ask a doctor if rash and irritation develops and lasts." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 50 g Jar Carton L'BEL PARIS REGRESSION JOUR protective complex against the first signs of age with spf 15 facial day cream normal to dry skin 50 g e (1.7 oz.) Principal Display Panel - 50 g Jar Carton", "PRINCIPAL DISPLAY PANEL - 5 g Jar Carton L'BEL PARIS REGRESSION JOUR protective complex against the first signs of age with spf 15 facial day cream normal to dry skin 5 g e (.17 oz.) Principal Display Panel - 5 g Jar Carton" ], "indications_and_usage": [ "Uses helps prevent sunburn higher SPF gives more sunburn protection provides moderate protection against sunburn" ], "set_id": "024de8f0-1d3a-4761-8674-5d1a8ac9133c", "id": "35041b4f-d141-4cf0-91c9-829ff347fe90", "active_ingredient": [ "Active Ingredients Avobenzone (2 %), Ensulizole (1 %), Octinoxate (7.5 %), Oxybenzone (2 %)" ] }, { "effective_time": "20091117", "inactive_ingredient": [ "Inactive ingredients Water, Dimethyl Ether, Octyldodecyl Neopentanoate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, C12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Glycerin, Cetyl Phosphate, Microcrystalline Cellulose, Caprylyl Glycol, Phenoxyethanol, Methylparaben, Chlorphenesin, Potassium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propylparaben, Cellulose Gum, Disodium EDTA, Ethylparaben, Butylparaben, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Fragrance" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. Flammable Do not use near heat, flame, or while smoking. When using this product Avoid spraying in eyes. Rinse with water to remove. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product Avoid spraying in eyes. Rinse with water to remove. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F." ], "questions": [ "Questions? 1-877-546-2273 M–F, 8 am to 4 pm CT Serious side effects associated with use of this product may be reported to this number." ], "spl_product_data_elements": [ "HUGGIES Little Swimmers Avobenzone, Octinoxate, Octisalate, Octocrylene, and Oxybenzone Avobenzone Avobenzone Octinoxate Octinoxate Octisalate Octisalate Octocrylene Octocrylene Oxybenzone Oxybenzone" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Shake well before use. Apply generously and evenly onto all exposed areas 15 minutes before sun exposure and as needed. Spray into hands to apply to face. Reapply as needed or after towel drying, swimming or sweating. Ask a doctor before use on children under six months of age. Use in well-ventilated area." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by Kimberly-Clark Global Sales, LLC, Neenah, WI 54956. Made in the U.S." ], "stop_use": [ "Stop use and ask a doctor if rash or irritation develops and lasts." ], "storage_and_handling": [ "Other information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun. May stain some fabrics. Avoid long term storage above 104°F." ], "do_not_use": [ "Flammable Do not use near heat, flame, or while smoking." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 170 g Bottle Very Water Resistant HUGGIES ® Little Swimmers ® Moisturizing Sunscreen Continuous Spray Lotion Shows Where It Goes SPF 50 UVB Advanced UVA/UVB Protection With Parsol ® 1789 • a UVA Absorber NET WT. 6 OZ (170g) Principal Display Panel - 170 g Bottle" ], "indications_and_usage": [ "Uses Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of activity in the water or sweating." ], "set_id": "026de33c-de06-436b-91c1-8070c4796330", "id": "2654456c-26c0-4eac-af10-e5759ff1b2de", "active_ingredient": [ "Active ingredients Avobenzone 1%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 0.8%, Oxybenzone 5%" ] }, { "effective_time": "20100611", "inactive_ingredient": [ "Inactive ingredients Aqua (Water), Butylene glycol, C12-15 alkyl benzoate, Steareth-21, Cyclopentasiloxane, Dimethicone, Mica, Cetyl alcohol, Kaolin, Cyclohexasiloxane, Steareth-2, Propylene glycol, Phenoxyethanol, Lauryl methacrylate/glycol dimethacrylate cross polymer, Oryza sativa (Rice) starch, Tocopheryl acetate, Sodium polyacrylate, Methylparaben, Xanthan gum, Camelia oleifera leaf extract, Propylparaben, Talc, Alumina, Citric Acid, Retinyl palmitate, Tetrasodium EDTA, Glycerin, Laminaria digitata extract, Zinc chloride, BHT, Tetrasodium pyrophospate, Butylparaben, Isobutylparaben, Ethylparaben, Tocopherol, [+/- CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxide), CI 77499 (Iron oxide)]." ], "purpose": [ "Uses Provides moderate protection against adverse effects of the sun Higher SPF gives more protection" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help." ], "questions": [ "Questions? 1-866-75-BOOTS", "USA: Questions? 1-866-75-BOOTS" ], "spl_product_data_elements": [ "No7 Intelligent Balance Foundation Sunscreen SPF12 Almond 35 Octinoxate and Titanium Dioxide OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER BUTYLENE GLYCOL C12-15 ALKYL BENZOATE CYCLOMETHICONE 5 DIMETHICONE CETYL ALCOHOL KAOLIN CYCLOMETHICONE 6 STEARETH-2 PROPYLENE GLYCOL PHENOXYETHANOL STARCH, RICE .ALPHA.-TOCOPHEROL ACETATE, D- METHYLPARABEN XANTHAN GUM PROPYLPARABEN TALC ALUMINUM OXIDE ANHYDROUS CITRIC ACID VITAMIN A PALMITATE EDETATE SODIUM GLYCERIN LAMINARIA DIGITATA ZINC CHLORIDE BUTYLATED HYDROXYTOLUENE SODIUM PYROPHOSPHATE BUTYLPARABEN ISOBUTYLPARABEN ETHYLPARABEN ALPHA-TOCOPHEROL FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "description": [ "Goodbye shine... Find your natural balance with this oil-free moisturising and mattifying foundation, for a flawless finish that helps prevent shine breakthrough for up to 12 hours. Fragrance free and easy to blend without blocking your pores. With vitamins. Ready to face the day... Shake well before use. Blend on smoothly and evenly with your fingers or a sponge, working downwards and outwards from the centre of your face. Non-pore blocking.", "Find your natural balance with this oil-free moisturising and mattifying foundaiton, for a flawless finish that helps prevent shine breakthrough for up to 12 hours. Shake well before use. Blend on smoothly and evenly with your fingers or a sponge. Non-pore blocking." ], "warnings_and_cautions": [ "Warnings For external use only When using this product keep out of eyes. Rinse with water to remove" ], "ask_doctor": [ "Stop use and ask a doctor if rash or irritation develops and lasts" ], "openfda": {}, "version": "1", "storage_and_handling": [ "Other Information Do not store above 30 0 C or 86 0 F" ], "information_for_patients": [ "www.boots.com Mfd in France for BBI Ltd NG2 3AA. UK Dist in the USA by Boots Retail USA Inc. Stamford CT 06901", "www.boots.com Mfd in France for BBI Ltd NG2 3AA. UK Dist in the USA by Boots Retail USA Inc. Stamford CT 06901" ], "package_label_principal_display_panel": [ "Carton principal display panel No7 Intelligent Balance Foundation For a flawless matte finish Sunscreen SPF 12 Hypo-allergenic Boots 30ml e 1 US Fl. Oz Intelligent Balance Fnd carton.jpg Intelligent Balance Fnd carton", "Bottle principal display panel Intelligent Balance Foundation Sunscreen SPF 12 Hypo-allergenic Boots 30ml e 1 US Fl. Oz Intelligent Balance Fnd bottle labels.jpg Intelligent Balance Fnd bottle labels" ], "indications_and_usage": [ "Directions Use as a normal foundation Apply evenly at least 15 minutes before sun exposure Reapply as needed Not intended for children under the age of 12 Not intended for protection while sunbathing" ], "set_id": "029ac837-8e5a-463b-a974-7ed45cd515f8", "id": "a0df2e40-1da9-4c0d-896f-e3651d28ea4d", "active_ingredient": [ "Active Ingredients Purpose Octinoxate 5% Sunscreens Titanium Dioxide 1.9%", "Bottle label Active Ingredients: Octinoxate 5% Titanium Dioxide 1.9%" ] }, { "effective_time": "20110701", "inactive_ingredient": [ "Inactive Ingredients petrolatum, lanolin, cod liver oil (contains vitamin A and vitamin D), purified water, talcum, methylparaben, fragrance, butylated hydroxyanisole" ], "purpose": [ "Uses - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness" ], "keep_out_of_reach_of_children": [ "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product - do not get into eyes Stop use and ask a doctor if: - condition worsens - symptoms last more than 7 days or clear up and occur again within a few days. Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center right away" ], "spl_product_data_elements": [ "Walgreen Maximum Strength Diaper Rash ZINC OXIDE ZINC OXIDE ZINC OXIDE PETROLATUM LANOLIN METHYLPARABEN BUTYLATED HYDROXYANISOLE WATER TALC COD LIVER OIL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions - change wet and soiled diapers promptly - cleanse the diaper area - allow to dry - apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged Other information Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Uses - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness" ], "set_id": "029b63cc-ca66-447f-9fb2-dacee3cce3e7", "id": "798bc7cd-956d-4936-bb3e-38ce0394308a", "active_ingredient": [ "Active ingredient Purpose Zinc Oxide. 40%.......................................Skin protectant" ] }, { "effective_time": "20130121", "inactive_ingredient": [ "acetylated lanolin alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PEG-20 methyl glucose distearate, polyoxyethylene 100 stearyl ether, propylene glycol, propylparaben, stearic acid, stearyl alcohol, triethanolamine, water" ], "keep_out_of_reach_of_children": [ "If swallowed, get medical help or contact a Poison Control Center immediately." ], "purpose": [ "" ], "warnings": [ "For external use only Do not use on wounds or damaged skin" ], "when_using": [ "When using this product you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. avoid contact with eyes, lips, nose or mucous membranes do not tightly wrap or bandage the treated area do not apply heat to the treated area immediately before or after use" ], "questions": [ "Questions or comments? Call 1-800-645-2158 9 am - 5 pm EST, Monday - Friday" ], "spl_product_data_elements": [ "Capsaicin Capsaicin External Analgesic Capsaicin Capsaicin ACETYLATED LANOLIN ALCOHOLS cetyl acetate methylparaben propylene glycol propylparaben stearic acid stearyl alcohol TROLAMINE water" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Adults and children 12 years and older: apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands, wash hands thoroughly with soap and water immediately after application for optimum results, apply 3 to 4 times daily Children under 12 years: ask a doctor Uses temporary relieves minor aches and pains of muscles and joints due to - simple backache - arthritis - strains - sprains Other information store at room temperature 15C-30C (59F-86F)" ], "stop_use": [ "Stop use and ask doctor if condition worsens or does not improve after regular use severe burning persists or blistering occurs" ], "package_label_principal_display_panel": [ "Capsaicin Cream, 0.025% External Analgesic Penetrating Pain Relief Net Wt 2.1 oz (60 g) image of package label" ], "indications_and_usage": [ "" ], "set_id": "029d398c-ff6d-4e5e-ba39-7909c6d196cb", "id": "eb329227-3511-4647-818b-da157c19c85b", "active_ingredient": [ "Active ingredient Capsaicin 0.025%" ] }, { "effective_time": "20121027", "inactive_ingredient": [ "Inactives. Inactive ingredients Aqua (Water), C12-15 alkyl benzoate, Glycerin, Butylene glycol, Cyclopentasiloxane, Mica, Glyceryl stearate, Petrolatum, Paraffinum liquidum (Mineral oil), Dimethicone, Cetearyl alcohol, PEG-100 stearate, Cyclohexasiloxane, Tribehenin, Rosa moschata seed oil, Phenoxyethanol, Alcohol denat., Methylparaben, Sodium stearoyl lactylate, Ascorbyl glucoside, Polacrylamide, Xanthan gum, Ethylparaben, Sodium polacrylate, C13-14 iosparaffin, Sodium hyaluronate, Tetrasodium ETA, Potassium hydroxide, Laureth-7, Dimethylmethoxy chromanol, Phyllanthus emblica fruit extract, Ceramide 3, Ginkgo biloba leaf extract, Ascorbyl palmitate, (+/- (May contain) CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides)." ], "purpose": [ "Purpose section Uses helps prevent sunburn" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "questions": [ "Questions. USA: Questions? 1-866-75-BOOTS." ], "spl_product_data_elements": [ "No7 Dual Action Tinted Moisturiser Medium Avobenzone, Octisalate and Octocrylene AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER C12-15 ALKYL BENZOATE GLYCERIN BUTYLENE GLYCOL CYCLOMETHICONE 5 MICA GLYCERYL MONOSTEARATE PETROLATUM MINERAL OIL DIMETHICONE CETOSTEARYL ALCOHOL PEG-100 STEARATE CYCLOMETHICONE 6 TRIBEHENIN ROSA MOSCHATA SEED OIL PHENOXYETHANOL METHYLPARABEN SODIUM STEAROYL LACTYLATE ASCORBYL GLUCOSIDE POLYACRYLAMIDE (1300000 MW) XANTHAN GUM ETHYLPARABEN SODIUM POLYACRYLATE (8000 MW) C13-14 ISOPARAFFIN HYALURONATE SODIUM EDETATE SODIUM TETRAHYDRATE POTASSIUM HYDROXIDE LAURETH-7 PHYLLANTHUS EMBLICA FRUIT JUICE CERAMIDE 3 GINKGO BILOBA LEAF OIL ASCORBYL PALMITATE TITANIUM DIOXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERRIC FERROCYANIDE" ], "description": [ "Description. Beautiful Protection. Achieve natural, skin perfecting colour with this sheer, light diffusing, tinted moisturiser. It delivers all day hydration and a powerful antioxidant complex to defend your skin from the ageing effects of the sun and the environment. For Best Results: Shake well before use. Smooth on evenly, just like your usual moisturiser. Hypo-allergenic: Because all skin can have sensitive moments, all our foundation products are hypo-allergenic using ingredients we know and trust.", "Description. Beautiful Protection. Achieve natural, skin perfecting colour with this sheer, light diffusing tinted moisturiser. It delivers all day hydrtion and a powerful antioxidant complex to defend your skin from the ageing effects of the sun and the environment. For Best Results: Shake well before use. Smooth on evenly, just like your usual moisturiser." ], "warnings_and_cautions": [ "Warnings. Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse wither water to remove.", "Warnings. Warning: Avoid contact with eyes. If product gets into the eyes rinse well with water immediately." ], "ask_doctor": [ "Ask Doctor. Stop use and ask a doctor if rash occurs." ], "openfda": {}, "version": "1", "storage_and_handling": [ "Storage. Other information protect the product in this ocntainer from excessive heat and direct sun." ], "information_for_patients": [ "Information for patients. The Boots Company PLC Nottingham England NG2 3AA Dist by Boots Retail USA Inc Norwalk CT 06851 USA Made in France www.boots.com .", "Information for patients. The Boots Company PLC Nottingham England NG2 3AA Dist by Boots Retail USA Inc Norwalk CT 06851 USA Made in France www.boots.com ." ], "package_label_principal_display_panel": [ "carton label. carton label carton label" ], "indications_and_usage": [ "Indications. Directions apply liberally 15 minutes bfore sun exposure reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating. children under 6 months of age: Ask a doctor. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses." ], "set_id": "02e2d98f-e49e-4ff4-a95a-a085da3cfbdd", "id": "aee6a64c-183b-4dc4-b9b6-de9e98fbdc59", "active_ingredient": [ "active ingredients Drug Facts Active Ingredients Avobenzone 3%, Octisalate 2%, Octocrylene 4% Purpose Sunscreen", "Jar front and active ingredients. No7 Dual Action Tinted Moisturiser Sunscreen Broad Spectrum SPF 15 All skin types Long lasting hydration, environmental protection and beautiful sheer colour Hypo-allergenic 50ml 1.6 US Fl Oz Active ingredients: Avobenzone 3%, Octisalate 2%, Octocrylene 4%." ] }, { "effective_time": "20100318", "inactive_ingredient": [ "Non-medicinal Ingredients/ Ingrédients non médicinaux : Aqua, Isohexadecane, Cetyl Dimethicone Copolyol, Caprylic/Capric Triglycerides, Stearalkonium Hectorite, Propylene Carbonate, PEG-8, Caprylyl Glycol, Sodium Chloride, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Glycerin, Sodium Citrate, Disodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Retinyl Palmitate, Sodium Ascorbyl Phosphate, C30-38 Olefin/Isopropoyl Maleate/MA Copolymer." ], "precautions": [ "Caution: For external use only. Discontinue use if skin irritation develops or increases. If irritation persists, consult a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Consult a doctor before using on children under 6 months. Use in well-ventilated area. May stain certain surfaces and fabrics. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container or store at temperatures over 50ºC." ], "warnings": [ "Mise en garde : Pour usage externe seulement. Cesser l’emploi du produit si une irritation cutanée apparaît ou si elle s’aggrave. Si l’irritation persiste, consulter un médecin. Éviter tout contact avec les yeux. En cas de contact, rincer abondamment avec de l’eau. Garder hors de la portée des enfants. Consulter un médecin avant d’utiliser pour un enfant de moins de six mois. Utiliser dans un endroit bien aéré. Ce produit peut abîmer certaines surfaces et certains tissus. Contenu sous pression . Ne pas placer dans l’eau chaude ni près des radiateurs , poêles ou autres sources de chaleur . Ne pas percer le contenant ni le jeter au feu , ni le conserver à des températures dépassant 50 °C." ], "questions": [ "QUESTIONS/IDÉES 1-888-SUN-TIPS DISTRIBUTED BY/DISTRIBUÉ PAR: ENERGIZER CANADA INC., WALKERTON, ON N0G 2V0 Made in U.S.A./Fabriqué aux États-Unis © 2009 Sun Pharmaceuticals, LLC" ], "spl_product_data_elements": [ "Banana Boat Kids Tear Free Sunscreen SPF 60 Homosalate and Octinoxate and Octisalate and Avobenzone and Octocrylene HOMOSALATE HOMOSALATE OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE MEDIUM-CHAIN TRIGLYCERIDES PROPYLENE CARBONATE CAPRYLYL GLYCOL SODIUM CHLORIDE PHENOXYETHANOL METHYLPARABEN BUTYLPARABEN ETHYLPARABEN PROPYLPARABEN ISOBUTYLPARABEN GLYCERIN SODIUM CITRATE EDETATE DISODIUM ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE, D- VITAMIN A PALMITATE SODIUM ASCORBYL PHOSPHATE" ], "description": [ "Purpose Sunscreen" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Apply liberally 15 to 30 minutes before sun exposure. Do not spray directly into face. Spray on hands to apply to face. Rub into skin. Reapply as needed or after swimming, towel drying, perspiring heavily, washing or vigorous activity." ], "spl_unclassified_section": [ "" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Alcohol-Free Sans alcool Ultra Mist TM New! Nouveau! Banana Boat TM Kids Tear Free Sans Iarmes Sunscreen Spray Écran solaire en vaporisateur pour enfants SPF/FPS 60 Broad Spectrum Écran à large spectre UVA/UVB Protection Goes on white Lotion blanche à l’application Waterproof Hydrofuge 180 ml PRINCIPAL DISPLAY PANEL Banana Boat Kids Tear-Free Sunscreen Spray SPF 60" ], "indications_and_usage": [ "Mode d’emploi : Appliquer généreusement de 15 à 30 minutes avant l’exposition au soleil. Ne pas vaporiser directement sur le visage. Vaporiser d’abord le produit dans les mains, puis appliquer sur le visage. Faire pénétrer dans la peau en frottant. Réappliquer au besoin ou après une baignade, une forte transpiration, une activité vigoureuse, s’être séché à la serviette ou s’être lavé." ], "set_id": "0329bfae-3f38-4fcd-be77-f92c67657bb5", "id": "9f025323-11fe-4dd4-9624-2c4a03815ab9", "active_ingredient": [ "Active Ingredients Homosalate 0.15mL / 1mL Octinoxate 0.075mL / 1mL Octisalate 0.05mL / 1mL Avobenzone 0.03mL / 1mL Octocrylene 0.024mL / 1mL", "Medicinal Ingredients (% w/w)/ Ingrédients médicinaux (% p/p): Homosalate 15.0%, Octinoxate 7.5%, Octisalate 5.0%, Avobenzone 3.0%, Octocrylene/Octocrylène 2.4%." ] }, { "effective_time": "20140306", "inactive_ingredient": [ "Inactive Ingredients aloe barbadensis gel, aqua, C12-15 alkyl benzoate, dimethicone, glyceryl stearate, L-Carnoside, methylparaben, microcrystalline cellulose, panthenol, paraffinum liquidum, parfum, PEG-100 stearate, propylene glycol, propylparaben, prunus amygdalus dulcis oil, sorbitan stearate, tocopherol, zinc oxide." ], "purpose": [ "Attends Professional Care Prevents. Treats. Protects. 3in1 Attends Daily Barrier S[ray Zinc Oxide & Dimethicone Skin Protectant Gentle enough for daily use Convenient and easy to use Pump Spray No rubbing No staining No stinging (Spanish Panel) Prevents diaper rash Treats irritated, chafed skin Provides protective barrier to help keep skin drier (Spanish Section Dermatologically Tested Net Wt. 3.5 oz (99.2 g)" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only When using this product Do not get into eyes Stop use and ask a doctor if Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days" ], "spl_product_data_elements": [ "Attends Daily Barrier Dimethicone, Zinc Oxide ZINC OXIDE ZINC CATION DIMETHICONE DIMETHICONE ALOE VERA LEAF WATER C12-15 ALKYL BENZOATE GLYCERYL MONOSTEARATE CARNOSINE METHYLPARABEN CELLULOSE, MICROCRYSTALLINE PANTHENOL MINERAL OIL PEG-100 STEARATE PROPYLENE GLYCOL PROPYLPARABEN ALMOND OIL SORBITAN MONOSTEARATE TOCOPHEROL" ], "other_safety_information": [ "Other Information Store between 59-77oF (15-25oC) Lot No & Exp date: see bottom of bottle Questions? Call 1-800-428-8363 Manufactured in Belgium Distributed by: Attends Healthcare Products, Inc. Greenville, NC 27834 www.Attends.com" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Cleanse the diaper area and allow to dry Shake bottle well before every use Change wet and soiled diapers promptly Spray 4-6 inches from skin. No rub in is required Apply product liberally as often as necessary, with each dipaer change, especially at bedtime or any time exposure to wet diapers may be prolonged" ], "package_label_principal_display_panel": [ "label image" ], "indications_and_usage": [ "Uses Prevents diaper rash Protects chafed skin due to diaper rash Helps protect skin for wetness" ], "set_id": "03319707-8c1d-408c-b173-3c384ef1271c", "id": "9194048e-5b6d-4f5d-b410-79cca5382ff2", "active_ingredient": [ "Active Ingredient Purpose Dimethicone 2% ............................... Skin Protectant Zinc Oxide 4% .................................. Skin Protectant" ] }, { "effective_time": "20100714", "inactive_ingredient": [ "Inactive ingredients: WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, GLYCERIN, ALCOHOL DENAT., DIMETHICONE, TALC, NEOPENTYL GLYCOL DIETHYLHEXANOATE, PEG-10 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, METHYLPARABEN, PEG-7 DIMETHICONE, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, IRON OXIDES(CI 77491), IRON OXIDES(CI 77492), STEARIC ACID, IRON OXIDES(CI 77499), PROPYLPARABEN, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) FLOWER EXTRACT, ALOE FEROX LEAF EXTRACT" ], "package_label_principal_display_panel": [ "Image of carton" ], "spl_product_data_elements": [ "HYDRO SPLASH BB SPF20 PA TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM" ], "description": [ "Warnings: When using this product Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if Rash or irritation develops and lasts. Directions: Apply evenly before sun exposure and as needed. Children under 6months of age; ask a doctor." ], "set_id": "03382d4f-0241-43c6-b6b6-b6c6ccd05b50", "id": "2c75cdc9-d568-4d54-84d5-9447395ebd7f", "openfda": {}, "version": "1", "active_ingredient": [ "Active Ingredient: TITANIUM DIOXIDE" ] }, { "effective_time": "20151104", "inactive_ingredient": [ "Inactive Ingredients: Water (Aqua), Cyclomethicone, Phenyl Trimethicone, Butylene Glycol, PEG/PPG-18/18 Dimethicone, Isononyl Isononanoate, Polysilicone-11, Diisopropyl Dimer Dilinoleate, Ethylhexyl Hydroxystearate, C18-36 Acid Triglyceride, Caviar Extract, Algae Extract, Glycoproteins*, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Glycyrrhiza Glabra (Licorice) Root Extract, Lactobacillus Ferment, Tocopheryl Acetate, Glycine Soja (Soybean) Oil, Malt Extract, Lactobacillus/Algae Extract Ferment, Panthenol, Hydrolyzed Wheat Protein, Arnica Montana Flower Extract, Ceramide 3, Tocopherol, Glycerin, Phospholipids, Sodium PCA, Lysine, Proline, Glycine, Arginine, Methionine, Petrolatum, Dimethicone, Tocopheryl Linoleate, Acrylates Copolymer, Propylene Glycol, Polymethyl Methacrylate, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Methicone, Xanthan Gum, Glucuronic Acid, Trihydroxystearin, Sodium Chloride, Fragrance (Parfum), Benzyl Alcohol, Linalool, Hydroxycitronellal, Alpha-Isomethyl Ionone, Amyl Cinnamal, Hexyl Cinnamal, Evernia Furfuracea (Treemoss) Extract, Geraniol, Benzyl Benzoate, Butylphenyl Methylpropional, Methylparaben, Propylparaben, Phenoxyethanol, Ethylparaben, Butylparaben, Isobutylparaben, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499) (i71), Petrolatum, Isopropyl Palmitate, Isostearyl Behenate, Silica, Microcrystalline (Cera Microcristallina) Wax, Dimethicone, Nylon-12, Ozokerite, Glyceryl Dibehenate, Polymethyl Methacrylate, Mica, Caviar Extract, Glycoproteins*, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Algae Extract, Lactobacillus Ferment, Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Extract, Camellia Sinensis Leaf Extract, Anthemis Nobilis (Chamomile) Flower Extract, Hydrolyzed Malt Extract, Hydrolyzed Wheat Protein, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Glycine Soja (Soybean) Oil, Butylene Glycol, Glycerin, Tribehenin, Triethanolamine, Water (Aqua), Glycine, Arginine, Glyceryl Behenate, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Isopropyl Myristate, Isopropyl Titanium Triisostearate, Methionine, Polyglucuronic Acid, Methylparaben, Propylparaben, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499) (i72)" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only" ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or comments? Call toll free 1-800-821-5718 or visit www.laprairie.com" ], "spl_product_data_elements": [ "SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Soft Beige OCTINOXATE WATER CYCLOMETHICONE PHENYL TRIMETHICONE BUTYLENE GLYCOL DIMETHICONE POLYETHYLENE GLYCOL 900 ISONONYL ISONONANOATE ETHYLHEXYL HYDROXYSTEARATE C18-36 ACID TRIGLYCERIDE CAVIAR, UNSPECIFIED PANAX GINSENG ROOT WATER EQUISETUM ARVENSE BRANCH GLYCYRRHIZA GLABRA SOYBEAN OIL PANTHENOL HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) ARNICA MONTANA FLOWER CERAMIDE 3 GLYCERIN SODIUM PYRROLIDONE CARBOXYLATE LYSINE PROLINE GLYCINE ARGININE METHIONINE PETROLATUM PROPYLENE GLYCOL XANTHAN GUM GLUCURONIC ACID TRIHYDROXYSTEARIN SODIUM CHLORIDE BENZYL ALCOHOL HYDROXYCITRONELLAL ISOMETHYL-.ALPHA.-IONONE .ALPHA.-AMYLCINNAMALDEHYDE GERANIOL BENZYL BENZOATE BUTYLPHENYL METHYLPROPIONAL METHYLPARABEN PROPYLPARABEN PHENOXYETHANOL ETHYLPARABEN BUTYLPARABEN ISOBUTYLPARABEN TITANIUM DIOXIDE ISOPROPYL PALMITATE SILICON DIOXIDE MICROCRYSTALLINE WAX GLYCERYL BEHENATE MICA BANCHA TEA LEAF/TWIG CHAMAEMELUM NOBILE FLOWER ASCORBYL PALMITATE OCTINOXATE OCTINOXATE" ], "description": [ "SKIN CAVIAR FOUNDATION • DERMO CAVIAR FOND DE TEINT SUNSCREEN • CREME SOLAIRE SPF 15 30 ml e / 1.0 FL. OZ. MADE IN USA - FABRIQUE AUX ETATS-UNIS LABORATOIRES LA PRAIRIE S.A CLARENS/MONTREUX • ZURICH D-78532 BADEN-BADEN MILANO • PARIS LA PRAIRIE, INC. DISTR. NEW YORK, N.Y. 10019 SHAKE WELL / BIEN AGITER" ], "openfda": {}, "version": "6", "dosage_and_administration": [ "Directions: • apply daily after cleansing and toning • smooth over face and throat • apply liberally 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating" ], "stop_use": [ "Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "spl_unclassified_section": [ "Other Information • Protect the product in this container from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "LABORATOIRES LA PRAIRIE S.A., CLARENS/MONTREUX • ZÜRICH • D-BADEN-BADEN • MILANO • PARIS LA PRAIRIE, INC., DISTR., NEW YORK, N.Y. 10019 PORCELAINE BLUSH Active Ingredient: Octinoxate 6.0% SEE PACKAGE INSERT FOR WARNING STATEMENT MADE IN USA / FABRIQUE AUX ETATS-UNIS CONCEALER / ANTI-CERNES 2 g / NET WT. 0.07 OZ. FOUNDATION / FOND DE TEINT 30 ml e / 1.0 FL. OZ. SHAKE WELL / BIEN AGITER SKIN CAVIAR CONCEALER . FOUNDATION SPF 15 la prairie SWITZERLAND 30ml e / 1.0 FL. OZ.", "Product Labels Soft Beige Skin Caviar Label Skin Caviar Carton" ], "indications_and_usage": [ "Uses: • helps prevent sunburn" ], "set_id": "033c1628-14b6-4c58-ad7a-03dc330a6d9d", "id": "23bb000b-5862-43c7-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Octinoxate 6.0% Purpose Sunscreen" ] }, { "effective_time": "20110901", "inactive_ingredient": [ "aloe barabardensis leaf Juice , water , mineral oil , glyceryl stearate , PEG-100 stearte , cetyl alcohol , cetearyl alcohol, polysorbate 60 , propylene glycol, stearic acid , hydrogenated polyisobutene, dimethicone, triethanolamine , salicylic acid, imidazolidinyl urea, chondrus crispus (carrageenan) , methylparaben, propylparaben,mentha piperita (peppermint oil), chloroxylenol, dmdm hydantoin" ], "purpose": [ "Purpose : External Analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children : In case of accidental ingestion, get medical help or contact a Poison Control center right away." ], "warnings": [ "Warnings: For external use only ." ], "spl_product_data_elements": [ "Miracle Foot Repair Menthol MENTHOL MENTHOL ALOE VERA LEAF Water MINERAL OIL Stearic Acid PEG-100 STEARATE GLYCERYL MONOSTEARATE CETOSTEARYL ALCOHOL POLYSORBATE 60 PROPYLENE GLYCOL Cetyl Alcohol COCOA BUTTER TROLAMINE SALICYLIC ACID CHONDRUS CHAMOMILE Methylparaben Propylparaben DMDM HYDANTOIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions : adults and children 2 years and older apply as needed under 2 years ask a doctor. wash and dry skin apply liberatly over attached area and massage until absorbed ." ], "package_label_principal_display_panel": [ "" ], "indications_and_usage": [ "Uses: Temporary protects and helps relieve chapped or cracked skin" ], "set_id": "033c4d3c-8ad8-4d37-b700-c2557805bba8", "id": "42072e37-eb03-4d14-a0c8-b80adb46832f", "active_ingredient": [ "Active Ingredient : MENTHOL 0.1% Image of Tube" ] }, { "effective_time": "20100127", "inactive_ingredient": [ "Inactive Ingredients Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Butylparaben, Chlorophenesin, Disodium EDTA, Ethylparaben, Fragrance, Glyceryl Stearate, Green Tea (Camellia Sinensis) Leaf Extract, Iodopropynyl Butylcarbamate, Isopropyl Myristate, Methylparaben, Phenoxyethanol, Polyethylene, Potassium Cetyl Phosphate, Propylene Glycol, Propylparaben, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tocopheryl Acetate, Water." ], "purpose": [ "Uses • helps prevent sunburn • higher SPF gives more sunburn protection • helps protect the skin against the harmful effects of UVA and UVB rays • retains SPF after 80 minutes of activity in the water or sweating" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only When using this product avoid contact with the eyes. If contact occurs rinse thoroughly with water. Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately." ], "when_using": [ "When using this product avoid contact with the eyes. If contact occurs rinse thoroughly with water." ], "questions": [ "Questions or Comments? Call 1-877-212-1985 Mon-Fri" ], "spl_product_data_elements": [ "UltrasolSunscreen Sunscreen Lotion SPF45 Avobenzone, Octinoxate, Octisalate, Oxybenzone Avobenzone Avobenzone Octinoxate Octinoxate Octisalate Octisalate Oxybenzone Oxybenzone Butylparaben Chlorphenesin EDETATE DISODIUM Ethylparaben GLYCERYL MONOSTEARATE Isopropyl Myristate Methylparaben Phenoxyethanol Propylene Glycol Propylparaben Sodium Hydroxide Stearic Acid Stearyl Alcohol ALPHA-TOCOPHEROL ACETATE Water" ], "openfda": {}, "version": "3", "dosage_and_administration": [ "Directions • apply generously and evenly to all exposed areas before sun exposure • reapply as needed or after towel drying, swimming, perspiring or vigorous activity • children under 6 months of age: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if rash or irritation develops and lasts." ], "spl_unclassified_section": [ "Other Information • may stain some fabrics • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun." ], "package_label_principal_display_panel": [ "Dr. Fischer ULTRASOL Sunscreen Lotion SPF45 Broad Spectrum UVA and UVB Protection Dermatologist Recommended SCIENCE INSIDE TM SUPERIOR SUN TECHNOLOGY VERY WATER RESISTANT Hypoallergenic Sensitive Approved RECOMMENDED - SKIN CANCER FOUNDATION 250 ML. 8.45 FL. OZ. FISCHER PHARMACEUTICALS (Back of Package): Manufactured by: Fischer Pharmaceuticals Ltd. Bnei Brak, Israel, 51553 Made in Israel www.dr-fischer.com NO ANIMAL INGREDIENTS - NO ANIMAL TESTING 24m Dr. Fischer - Tried and Tested PDP and Back" ], "set_id": "035383ed-9ebb-4a75-9c3f-cde9ebe8fd4e", "id": "dc7380b8-5a08-450d-91fd-c863d62f69f6", "active_ingredient": [ "Drug Facts Active Ingredients Purpose Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 4.0% ....... Sunscreen" ] }, { "effective_time": "20120511", "inactive_ingredient": [ "Inactive Ingredients water, glycerin, isopropyl isostearate, boron nitride, sodium carboxymethyl beta-glucan, polyacrylamide, C13-14 isoparaffin, laureth-7, cetyl alcohol, stearyl alcohol, cyclopentasiloxane, dimethiconol, dimethicone, cetearyl alcohol, cetearyl glucoside, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, sorbitan stearate, panthenol (pro-vitamin B5), behenyl alcohol, tocopheryl acetate (vitamin E), benzyl alcohol, disodium EDTA, PEG-100 stearate, stearic acid, ascorbyl tetraisopalmitate, magnesium aspartate, zinc gluconate, copper gluconate, calcium gluconate, dihydroxyacetone" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Meijer Elements 7-in-1 Anti-Aging Vitamin Avobenzone, Octisalate and Octocrylene AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER GLYCERIN ISOPROPYL ISOSTEARATE BORON NITRIDE SODIUM STARCH GLYCOLATE TYPE A POTATO POLYACRYLAMIDE (10000 MW) C13-14 ISOPARAFFIN LAURETH-7 CETYL ALCOHOL STEARYL ALCOHOL CYCLOMETHICONE 5 DIMETHICONOL (250000 MW) DIMETHICONE CETOSTEARYL ALCOHOL CETEARYL GLUCOSIDE PHENOXYETHANOL METHYLPARABEN ETHYLPARABEN BUTYLPARABEN PROPYLPARABEN ISOBUTYLPARABEN SORBITAN MONOSTEARATE PANTHENOL DOCOSANOL .ALPHA.-TOCOPHEROL ACETATE BENZYL ALCOHOL EDETATE DISODIUM PEG-100 STEARATE STEARIC ACID ASCORBYL PALMITATE MAGNESIUM ASPARTATE ZINC GLUCONATE COPPER GLUCONATE CALCIUM GLUCONATE DIHYDROXYACETONE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Apply liberally 15 minutes before sun exposure. Children under 6 months of age: ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses" ], "stop_use": [ "Stop use and ask a doctor if rash occurs." ], "spl_unclassified_section": [ "Other Information protect the product in this container from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel meijer elements ® Anti-Aging Vitamin Complex 7-in-1 Broad Spectrum SPF15 Sunscreen Fragrance Free 7 anti-aging treatments in 1 vitamin and antioxidant moisturizer + broad spectrum SPF15 protection for younger looking skin *Compare to Olay ® Total Effects ® 7 in One Anti-Aging UV Moisturizer Fragrance-Free SPF 15 ingredients 1.7 FL OZ (50 mL) DIST. BY MEIJER DISTRIBUTION, INC. 2929 WALKER AVE. NW GRAND RAPIDS, MI 49544 www.meijer.com Manufactured in Israel 2F692 6E C4 Carton Label Carton Label" ], "indications_and_usage": [ "Uses helps prevent sunburn If used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "0390b39e-fc13-42bc-ae8a-71ee37520a91", "id": "deeb696f-3441-46ae-83c9-caa176af34b4", "active_ingredient": [ "Active ingredient Avobenzone 3.0% Octisalate 5.0% Octocrylene 8.0%" ] }, { "effective_time": "20141010", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? Call 1-866-923-4914" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information do not use if carton is opened, or if imprinted safety seal is broken or missing. see bottom panel for expiration date store between 20° to 25°C (68° to 77°F)" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "039b6b47-48d0-4a00-a927-c1ddebcf887f", "id": "689dc410-a14c-42c1-b295-a76a5e47612b", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each 5 mL teaspoonful) Cetirizine HCl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "spl_product_data_elements": [ "Childrens 24 Hour Allergy Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine acetic acid glycerin methylparaben propylene glycol propylparaben water sodium acetate anhydrous sucralose colorless to slightly yellow Sugar Free" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "DIST. BY MEIJER DISTRIBUTION, INC. 2929 WALKER AVE NW GRAND RAPIDS, MI 49544" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton NDC 41250-106-08 Compare to Children's Zyrtec ® active ingredient* meijer ™ Sugar Free 2 Years and Older Children's 24 Hour Allergy Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine Bubble Gum Flavor DYE-FREE Indoor & Outdoor Allergies 24 Hour Relief of: Sneezing / Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Dosing Cup Included 4 FL OZ (120 mL) PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton" ] }, { "effective_time": "20150829", "inactive_ingredient": [ "Inactive Ingredient: Dimethicone, Dimethicone Crosspolymer, Ethylhexyl Palmitate, Carotenoids, Bisabolol, Tocopheryl Acetate, Silica Dimethyl Silylate, Phenoxyehtanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben" ], "purpose": [ "Purpose: Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children If product is swallowed, get medical help or contact a poison control center right away" ], "warnings": [ "Warning: Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has only been shown to help prevent sunburn, not skin cancer or ealy skin aging. For external use only Do not use on damaged or broken skin" ], "when_using": [ "When using this product: Keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "ELF SPF 20 Sunscreen Face Primer Clear OCTINOXATE OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE ETHYLHEXYL PALMITATE .ALPHA.-BISABOLOL, (+/-)- SILICA DIMETHYL SILYLATE PHENOXYETHANOL METHYLPARABEN ETHYLPARABEN BUTYLPARABEN PROPYLPARABEN OCTISALATE OCTISALATE ISOBUTYLPARABEN DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) DIMETHICONE .ALPHA.-TOCOPHEROL ACETATE" ], "ask_doctor": [ "Stop Use and Ask a Doctor if: Rash occurs" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: For sunscreen use: Apply generously 15 min before sun exposure. Reapply every two hours. Use a water resistant sunscreen if swimming or sweating Children under six months of age: ask a doctor" ], "package_label_principal_display_panel": [ "label" ], "indications_and_usage": [ "Uses: Help prevent sunburn" ], "set_id": "03b0cb0b-fa58-40a7-8489-2650cdf7cfa7", "id": "7e9e9552-fc12-431e-8cb0-7c8fc64114f4", "active_ingredient": [ "Active Ingredient: OCTINOXATE: 7.5% OCTISALATE: 5.0% OXYBENONE: 4.0%" ] }, { "effective_time": "20120102", "inactive_ingredient": [ "INACTIVE INGREDIENTS Arginine, Ascorbyl Glucoside (Vitamin C), Bisabolol, Butylparaben, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Dimethicone, Ethylparaben, Fragrance, Glycerin, Glyceryl Stearate, Glycolic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isobutylparaben, Methylparaben, PEG/PPG-10/2 Ricinoleate, PEG-100 Stearate, PEG-8 Dimethicone, Phenoxyethanol, Polysorbate 60, Propylparaben, Purified Water, Sodium Hyaluronate (Hyaluronic Acid), Sodium Hydroxide, Squalane, Steareth-2, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E)" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "WARNINGS FOR EXTERNAL USE ONLY. Avoid contact with eyes. If contact occurs, rinse with water to remove. Stop use and consult a physician if rash or irritation develops. Keep out of reach of children." ], "when_using": [ "Avoid contact with eyes. If contact occurs, rinse with water to remove." ], "spl_product_data_elements": [ "OBAGI-C RX SYSTEM C-EXFOLIATING DAY with Vitamin C OCTISALATE, OCTINOXATE, and OXYBENZONE OCTISALATE OCTISALATE OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE ISOBUTYLPARABEN STEARETH-2 ASCORBYL GLUCOSIDE LEVOMENOL GLYCERIN EDETATE DISODIUM ALPHA-TOCOPHEROL ACETATE DIMETHICONE ARGININE WATER METHYLPARABEN PROPYLPARABEN GLYCOLIC ACID SQUALANE MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL MONOSTEARATE PEG-100 STEARATE CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER HYALURONATE SODIUM SODIUM HYDROXIDE PHENOXYETHANOL ETHYLPARABEN BUTYLPARABEN POLYSORBATE 60 PEG-8 DIMETHICONE PEG-8 RICINOLEATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Apply to the face and neck in the morning after Obagi-C Rx System C-Clarifying Serum and before C-SunGuard SPF 30. Massage in gently." ], "stop_use": [ "Stop use and consult a physician if rash or irritation develops." ], "spl_unclassified_section": [ "Dist. by OMP Inc., Long Beach, CA 90802" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 57 mL Carton OBAGI-C™ RX SYSTEM C-EXFOLIATING DAY LOTION SPF 12 WITH VITAMIN C AM 2 FL. OZ. (57 mL) Principal Display Panel - 57 mL Carton" ], "set_id": "03b61684-2ce4-4ac8-bec8-1e47fe179e88", "id": "6c4ef21b-f06a-4a19-b667-5bea96e12ada", "active_ingredient": [ "ACTIVE INGREDIENTS Octinoxate 7.50%, Octisalate 5.00%, Oxybenzone 4.00%" ] }, { "effective_time": "20151104", "inactive_ingredient": [ "Inactive Ingredients: Water (Aqua), Cyclomethicone, Phenyl Trimethicone, Butylene Glycol, PEG/PPG-18/18 Dimethicone, Isononyl Isononanoate, Polysilicone-11, Diisopropyl Dimer Dilinoleate, Ethylhexyl Hydroxystearate, C18-36 Acid Triglyceride, Caviar Extract, Algae Extract, Glycoproteins*, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Glycyrrhiza Glabra (Licorice) Root Extract, Lactobacillus Ferment, Tocopheryl Acetate, Glycine Soja (Soybean) Oil, Malt Extract, Lactobacillus/Algae Extract Ferment, Panthenol, Hydrolyzed Wheat Protein, Arnica Montana Flower Extract, Ceramide 3, Tocopherol, Glycerin, Phospholipids, Sodium PCA, Lysine, Proline, Glycine, Arginine, Methionine, Petrolatum, Dimethicone, Tocopheryl Linoleate, Acrylates Copolymer, Propylene Glycol, Polymethyl Methacrylate, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Methicone, Xanthan Gum, Glucuronic Acid, Trihydroxystearin, Sodium Chloride, Fragrance (Parfum), Benzyl Alcohol, Linalool, Hydroxycitronellal, Alpha-Isomethyl Ionone, Amyl Cinnamal, Hexyl Cinnamal, Evernia Furfuracea (Treemoss) Extract, Geraniol, Benzyl Benzoate, Butylphenyl Methylpropional, Methylparaben, Propylparaben, Phenoxyethanol, Ethylparaben, Butylparaben, Isobutylparaben, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499) (i71), Petrolatum, Isopropyl Palmitate, Isostearyl Behenate, Silica, Microcrystalline (Cera Microcristallina) Wax, Dimethicone, Nylon-12, Ozokerite, Glyceryl Dibehenate, Polymethyl Methacrylate, Mica, Caviar Extract, Glycoproteins*, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Algae Extract, Lactobacillus Ferment, Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender) Extract, Camellia Sinensis Leaf Extract, Anthemis Nobilis (Chamomile) Flower Extract, Hydrolyzed Malt Extract, Hydrolyzed Wheat Protein, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Glycine Soja (Soybean) Oil, Butylene Glycol, Glycerin, Tribehenin, Triethanolamine, Water (Aqua), Glycine, Arginine, Glyceryl Behenate, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Isopropyl Myristate, Isopropyl Titanium Triisostearate, Methionine, Polyglucuronic Acid, Methylparaben, Propylparaben, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499) (i72)" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. For external use only" ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or comments? Call toll free 1-800-821-5718 or visit www.laprairie.com" ], "spl_product_data_elements": [ "SKIN CAVIAR CONCEALER FOUNDATION SUNSCREEN SPF 15 - Soleil Peche OCTINOXATE WATER CYCLOMETHICONE PHENYL TRIMETHICONE BUTYLENE GLYCOL DIMETHICONE POLYETHYLENE GLYCOL 900 ISONONYL ISONONANOATE ETHYLHEXYL HYDROXYSTEARATE C18-36 ACID TRIGLYCERIDE CAVIAR, UNSPECIFIED PANAX GINSENG ROOT WATER EQUISETUM ARVENSE BRANCH GLYCYRRHIZA GLABRA SOYBEAN OIL PANTHENOL HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) ARNICA MONTANA FLOWER CERAMIDE 3 GLYCERIN SODIUM PYRROLIDONE CARBOXYLATE LYSINE PROLINE GLYCINE ARGININE METHIONINE PETROLATUM PROPYLENE GLYCOL XANTHAN GUM GLUCURONIC ACID TRIHYDROXYSTEARIN SODIUM CHLORIDE BENZYL ALCOHOL HYDROXYCITRONELLAL ISOMETHYL-.ALPHA.-IONONE .ALPHA.-AMYLCINNAMALDEHYDE GERANIOL BENZYL BENZOATE BUTYLPHENYL METHYLPROPIONAL METHYLPARABEN PROPYLPARABEN PHENOXYETHANOL ETHYLPARABEN BUTYLPARABEN ISOBUTYLPARABEN TITANIUM DIOXIDE ISOPROPYL PALMITATE SILICON DIOXIDE MICROCRYSTALLINE WAX GLYCERYL BEHENATE MICA BANCHA TEA LEAF/TWIG CHAMAEMELUM NOBILE FLOWER ASCORBYL PALMITATE OCTINOXATE OCTINOXATE" ], "openfda": {}, "version": "7", "dosage_and_administration": [ "Directions: • apply daily after cleansing and toning • smooth over face and throat • apply liberally 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating" ], "stop_use": [ "Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "spl_unclassified_section": [ "Other Information • Protect the product in this container from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "Soleil Peche Skin Caviar Label Skin Caviar Carton" ], "indications_and_usage": [ "Uses: • helps prevent sunburn" ], "set_id": "03c0ff1b-76a1-42fc-add9-5a80df524892", "id": "23bb000b-583f-43c7-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Octinoxate 6.0% Purpose Sunscreen" ] }, { "effective_time": "20121114", "inactive_ingredient": [ "INACTIVE INGREDIENTS: Water, Ethyhexyl Palmitate, Lauryl PEG-8 Dimethicone, Hexyldecanol, Cyclopentasiloxane, Hydrated Silica, Cyclohexasiloxane, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methcrylate Copolymer, Cetyl Dimethicone, Sodium Chloride, Beeswax, Microcrystalline Wax, Polyethylene, PEG-4 Laurate, Stearoxy dimethicone, PEG-4, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, OCtyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate,Silica, Methylparaben,Propylparaben, Disodium EDTA, Iodopropynyl Butylcarbamate, Fragrance." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "keep out of the reach of children. If swallowed get medical help or contact a poison control center right away." ], "warnings": [ "WARNINGS: FOR EXTERNAL USE ONLY. When using this product keep out of eyes. Rinse with water to remove. stop use and ask a doctor if rash or irritation develops and lasts keep out of the reach of children. If swallowed get medical help or contact a poison control center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Duane Reade Prevail Moisturizing Sunscreen SPF 30 AVOBENZONE AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE WATER ETHYLHEXYL PALMITATE OXYBENZONE OXYBENZONE HEXYLDECANOL CYCLOMETHICONE 5 HYDRATED SILICA CYCLOMETHICONE 6 BENZYL ALCOHOL SODIUM CHLORIDE YELLOW WAX MICROCRYSTALLINE WAX HIGH DENSITY POLYETHYLENE PEG-4 DILAURATE EDETATE DISODIUM POLYETHYLENE GLYCOL 200 PEG-8 DIMETHICONE ALOE VERA LEAF OCTYLDODECANOL VITAMIN A PALMITATE SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID METHYLPARABEN PROPYLPARABEN IODOPROPYNYL BUTYLCARBAMATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: apply generously and evenly before sun exposure and as needed Children under 6 months of age:ask a doctor reapplying frequently after towel drying, swimming or perspiring." ], "stop_use": [ "stop use and ask a doctor if rash or irritation develops and lasts" ], "spl_unclassified_section": [ "Other Information: May stain some fabrics. Sun Alert: Limiting sun exposure, wearing, protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun." ], "package_label_principal_display_panel": [ "Principal Display Panel PRevail moisturizing sunscreen spf 30 antioxidant-enriched uva/uvb protection hypoallergic oil-free 6.5 FL. OZ. (192 mL) ZDR015A0f.jpg ZDR015A0b.jpg" ], "indications_and_usage": [ "Uses Helps prevent sunburn Higher SPF gives more sunburn protection Retains SPF after 80 minutes of activity in the water" ], "set_id": "03de9560-6fdf-44e5-b63b-d8cba070d33d", "id": "7b73105e-5cb6-42ce-9f93-ef8daa2976e3", "active_ingredient": [ "ACTIVE INGREDIENTS: Avobenzone 1.0 % Octocrylene 4.5 % Oxybenzone 3.0%" ] }, { "effective_time": "20140113", "inactive_ingredient": [ "OTHER INGREDIENTS Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodiumm Salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben." ], "purpose": [ "PURPOSE Analgesic/Counterirritant External Analgesic" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not cover with bandage. Do not use on wounds or damaged skin. Consult physician for children under 12. Do not use if you are allergic to Menthol Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days Or rash, itching or excessive skin irritation occurs." ], "spl_product_data_elements": [ "MEDROX MENTHOL, CAPSAICIN MENTHOL MENTHOL CAPSAICIN CAPSAICIN WATER GLYCERIN POLYSORBATE 80 ALOE VERA LEAF EDETATE DISODIUM DIAZOLIDINYL UREA METHYLPARABEN IODOPROPYNYL BUTYLCARBAMATE PROPYLPARABEN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Adults and children 12 years and over apply to affected area: change patch 1 to 2 times daily Children under 12 years, consult physician before use How to apply: Clean and dry affected area Cut open pouch and remove patch Remove protective film and apply directly to area of pain Apply to affected area not more than 3 times daily Wash hands with soap after applying patch Reseal pouch containing unused patches" ], "package_label_principal_display_panel": [ "MEDROX Patch 5 Patches (33261-0884-01) IMAGE LABEL" ], "indications_and_usage": [ "USES Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness." ], "set_id": "03ef29a0-84bc-45aa-a9da-00ad42efabb7", "id": "c8bbb594-e795-431e-aeb8-800da6a7db1f", "active_ingredient": [ "ACTIVE INGREDIENTS Menthol 5.00% Capsaicin 0.0375%" ] }, { "effective_time": "20110727", "inactive_ingredient": [ "Inactive ingredients: CAVIAR EXTRACT, CYCLOPENTASILOXANE, WATER, ALCOHOL DENAT., BUTYLENE GLYCOL, GLYCERETH-26, BETAINE, BETA-GLUCAN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL POLYACRYLATE, TOCOPHERYL ACETATE, PROPYLENE GLYCOL, PEG-10 DIMETHICONE, BIOSACCHARIDE GUM-1, TRISILOXANE, NIACINAMIDE, SODIUM CHLORIDE, PEG/PPG-18/18 DIMETHICONE, PEG/PPG-17/6 COPOLYMER, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, DISTEARDIMONIUM HECTORITE, CYCLOMETHICONE, POLYSORBATE 20, CARBOMER, GLYCERIN, PROLINE, PALMITOYL TETRAPEPTIDE-7, PALMITOYL PENTAPEPTIDE-4, PALMITOYL OLIGOPEPTIDE, LENTINUS EDODES EXTRACT, LECITHIN, HYDROLYZED VEGETABLE PROTEIN, HYDROGENATED LECITHIN, GLYCINE SOJA (SOYBEAN) PROTEIN, PERSEA GRATISSIMA (AVOCADO) OIL, ADENOSINE TRIPHOSPHATE, ACETYL TYROSINE, ADENOSINE, DISODIUM EDTA, CHOLESTEROL, CERAMIDE 3, PHENOXYETHANOL, PROPYLPARABEN, METHYLPARABEN, FRAGRANCE, CARAMEL, GOLD" ], "purpose": [ "Purpose: This combination of cosmetics is used for your basic skin care and gives a benefit for Anti-wrinkle care." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children: Keep out of reach of children." ], "warnings": [ "Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation appear." ], "spl_product_data_elements": [ "GOLD CAVIAR SERUM DIMETHICONE DIMETHICONE DIMETHICONE CAVIAR CYCLOMETHICONE 5 WATER BUTYLENE GLYCOL GLYCERETH-26 BETAINE PROPYLENE GLYCOL BIOSACCHARIDE GUM-1 TRISILOXANE NIACINAMIDE SODIUM CHLORIDE JOJOBA OIL CYCLOMETHICONE POLYSORBATE 20 PHENOXYETHANOL GLYCERIN PROPYLPARABEN PROLINE PALMITOYL TETRAPEPTIDE-7 PALMITOYL PENTAPEPTIDE-4 METHYLPARABEN LECITHIN, SOYBEAN HYDROGENATED SOYBEAN LECITHIN SOYBEAN PERSEA AMERICANA VAR. AMERICANA LEAF ADENOSINE TRIPHOSPHATE ADENOSINE EDETATE DISODIUM CHOLESTEROL GOLD CERAMIDE 3 CARAMEL" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and administration: Take appropriate amount according to your skin condition and apply every morning and night." ], "package_label_principal_display_panel": [ "Image of carton" ], "indications_and_usage": [ "Indication and usage: Following toner, pour some on the palm of your hand and apply to skin gently. Press down lightly until absorbed." ], "set_id": "03f6044f-2cd0-47b7-ae5e-5fa287994df3", "id": "4b26437a-7999-4ae7-99a7-5bbbc01e6300", "active_ingredient": [ "Active ingredient: DIMETHICONE 7.8%" ] }, { "effective_time": "20120214", "inactive_ingredient": [ "Inactive Ingredients Water (Aqua), Butylene Glycol, Pentylene Glycol, Glyceryl Steararte, PEG-100 Stearate, Diisipropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Stearic Acid, Sorbitan Stearate, Cetearyl Alcohol, Ceteareth-20, Citrus Medica Limonum (Lemon) Peel extract, Calendula Officinalis Flower Extract, Glycolipids, Sodium Hyaluronate, Lecithin, Tcopherol, Hydrogen Peroxide, Dipotassium Glycyrrhizate, Punica Granatum Extract, Magnesium Ascorbyl Phosphate, Hydrolyzed Soy Flour, Avena Sativa (Oat) Kernel Protein, Palmitoyl Hydroxypropyltrimonium Amylopectin/Glycerin Crosspolymer, Vitis Vinefera (Grape) Seed Extract, Camellia Sinensis Leaf Extract, Oenothera Biennis (Evening Primrose) Oil, Borago Officinalis Seed Oil, Sodium PCA, Dimethicone, Ascorbyl Palmitate, Proylene Glycol, Carbomer, Sclerotium Gum, Aminimethyl Propanol, Chlorphenesin, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA, Linalool, Lavandula Angustifolia (Lavender) Oil." ], "purpose": [ "Purpose Hydrate and Protect" ], "warnings": [ "Warning For external use only. Avoid contact with eyes. Keep out of reach of children. If swallowed contact a Poison Control Center right away. Questions or Comments? 1-800-33-MURAD Murad.com" ], "questions": [ "Questions or Comments? 1-800-33-MURAD Murad.com" ], "spl_product_data_elements": [ "Perfecting Day Avobenzone, Homosalate, Octisalate, Octinoxate, Oxybenzone Avobenzone Avobenzone Homosalate Homosalate Octisalate Octisalate Octinoxate Octinoxate OXYBENZONE Oxybenzone Water Butylene Glycol Pentylene Glycol Glyceryl Monostearate PEG-100 Stearate Diisopropyl Sebacate Isodecyl Neopentanoate Lauryl Lactate Stearic Acid Sorbitan Monostearate CETOSTEARYL ALCOHOL Polyoxyl 20 Cetostearyl Ether Lemon Peel Calendula Officinalis Flower Glycyrrhizinate Dipotassium Hyaluronate Sodium LECITHIN, SOYBEAN Tocopherol Hydrogen Peroxide Pomegranate Seed Magnesium Ascorbyl Phosphate Evening Primrose Oil Oat Borage Oil VITIS VINIFERA SEED Green Tea Leaf Sodium Pyrrolidone Carboxylate Dimethicone Ascorbyl Palmitate Propylene Glycol Chlorphenesin Betasizofiran Aminomethylpropanol Phenoxyethanol Methylparaben Propylparaben Edetate Disodium Linalool, (+/-)- LAVENDER OIL" ], "openfda": {}, "version": "21161", "dosage_and_administration": [ "Directions Every day after cleansing, massage a thin layer over face, neck and chest. For optimal results, first apply recommended Murad treatment." ], "spl_unclassified_section": [ "" ], "package_label_principal_display_panel": [ "Package Label principal Display Panel image of tube image of carton" ], "indications_and_usage": [ "Use Rich moisturizing cream hydrates and protects to restore youthful skin Essential fatty acids provide superior hydration Soy Flour protects elasticity and softens lines Lecithin helps lock in moisture to restore suppleness" ], "set_id": "03f89b89-3576-48aa-9b5a-8663166ef362", "id": "8468340e-79d2-4ecd-9b81-34d64da35991", "active_ingredient": [ "Active Ingredients Avobenzone (2.0%) Homosalate (6.5%) Octisalate (5.0%) Octinoxate (7.5%) Oxybenzone (4.0%)" ] }, { "effective_time": "20130312", "inactive_ingredient": [ "Inactive Ingredients: Water, Sodium Xylenesulfonate, Dipropylene Glycol, Glycerin, Sodium PCA, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Polyquaternium-10, Fragrance, Disodium Phosphate, Cetyl Alcohol, Aloe Barbadensis Leaf juice, Citric Acid, Methylparaben, Propylparaben" ], "purpose": [ "Antibacterial" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "For external use only." ], "when_using": [ "When using this product avoid contact with eyes. In case of eye contact, flush with water." ], "questions": [ "Questions? 1-800-258-DIAL" ], "spl_product_data_elements": [ "Dial Complete Antibacterial Foaming Hand Washkitchen crisp limkitchen crisp lim kitchen crisp lime TRICLOSAN TRICLOSAN TRICLOSAN WATER SODIUM XYLENESULFONATE DIPROPYLENE GLYCOL GLYCERIN SODIUM PYRROLIDONE CARBOXYLATE AMMONIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE POLYQUATERNIUM-10 (400 MPA.S AT 2%) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS CETYL ALCOHOL ALOE VERA LEAF CITRIC ACID MONOHYDRATE METHYLPARABEN PROPYLPARABEN FD&C YELLOW NO. 5 D&C GREEN NO. 5" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions: Pump into dry hands. Lather vigorously for 15 seconds. Rinse and dry thoroughly." ], "stop_use": [ "Stop use and ask a doctor if irritation and redness develops." ], "package_label_principal_display_panel": [ "Label image image" ], "indications_and_usage": [ "For hand washing to decrease bacteria on the skin" ], "set_id": "0425844a-c5c2-425b-bef3-b77f062bf350", "id": "77f9abb5-5d4a-4886-8989-b8347281f7d2", "active_ingredient": [ "Active Ingredient - TRICLOSAN 0.46%" ] }, { "effective_time": "20140929", "inactive_ingredient": [ "Inactive ingredients diethylene glycol monoethyl ether acetate, cetanol, glycerol, glycerol monostearate, methylparaben, 2(2-aminoethoxy) ethanol, sorbitan sesquiolate, sodium polyacrylate, polysorbate 80, aloe barbadensis leaf extract, methyl orange- xylene cyanol solution, ethylenediaminetetracetic acid tetrasodium salt hydrate" ], "purpose": [ "Purpose Topical Analgesic Patch" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately." ], "warnings": [ "Warnings For external use only" ], "when_using": [ "When using this product - avoid contact with eyes - do not apply to wounds or damaged skin - do not bandage tightly - do not use with heating pad" ], "spl_product_data_elements": [ "PARAID Extra Strength Menthol Pain Relief Sleeve WRIST and Small Ankles and Elbows MENTHOL MENTHOL MENTHOL DIETHYLENE GLYCOL MONOETHYL ETHER CETYL ALCOHOL GLYCERYL MONOSTEARATE METHYLPARABEN MONOETHANOLAMINE SORBITAN SESQUIOLEATE SODIUM POLYACRYLATE (2500000 MW) POLYSORBATE 80 ALOE VERA LEAF METHYL ORANGE EDETIC ACID SOLASULFONE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions - Adults and children over 12 years: pull sleeve onto knee or large ankles or elbows untill the colored section of the sleeve is positioned directly over the affected area. Sleeve should feel snug but not tight. - Children 12 years or younger: consult a doctor." ], "stop_use": [ "Stop using and ask a doctor if redness is present or irritation develops. Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days" ], "package_label_principal_display_panel": [ "PARAID Extra Strength Menthol Pain Relief Sleeve WRIST & Small Ankles & Elbows (50076-301-01) Extra Strength Menthol 16% PARAID Menthol Pain Relief Sleeve WRIST & Small Ankles & Elbows Medicated Sleeve Pain Relieving Lotion on a Breathable Sleeve EXPANDS TO FIT 8\" TO 24\" IN CIRCUMFERENCE Contains 1 Sleeve Patch Smallsleeve" ], "indications_and_usage": [ "Uses For the temporary relief of minor aches and pains of muscles and joints associated with - arthritis - strains - bruises - sprains" ], "set_id": "04522c6d-ddbe-49ab-8cde-02d6d9d1faab", "id": "a11f1787-1e06-4672-9d22-b9cb4a1667f3", "active_ingredient": [ "Active Ingredient Menthol 16.0%" ] }, { "effective_time": "20140407", "purpose": [ "Purpose Antihistamine" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "when_using": [ "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery" ], "questions": [ "Questions? Call 1-800-200-6313" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use." ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F)" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat" ], "set_id": "045cfd34-271d-48ef-a92e-7c13b34253a3", "id": "5f7f713f-89c8-40ac-b47c-30619ce0c05c", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "active_ingredient": [ "Active ingredient (in each 5 mL teaspoonful) Cetirizine HCl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor
" ], "inactive_ingredient": [ "Inactive ingredients bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)." ], "spl_product_data_elements": [ "Leader Childrens Allergy Relief Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine acetic acid glycerin methylparaben propylene glycol propylparaben water sodium acetate anhydrous sucralose colorless to slightly yellow" ], "ask_doctor": [ "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017" ], "stop_use": [ "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "do_not_use": [ "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton LEADER ® NDC 37205-591-26 Compare to Children's Zytrec ® active ingredient † CHILDREN'S Allergy Relief Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine 24 Hour Sugar Free Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose Indoor & Outdoor Allergies Bubble Gum Flavor Ages two years and older ● SATISFACTION ● GUARANTEED 4 FL OZ (120 mL) Principal Display Panel - 120 mL Bottle Carton" ] }, { "effective_time": "20111112", "inactive_ingredient": [ "Inactive ingredients Deionized Water, Cyclomethicone, Mineral Oil, Lauryl PEG/PPG-18/18 Methicon, Cetyl dimethicone, Stearyl Dimethicone, Ceresine, Hydrogenated Castor Oil, Plankton extract, Propylene Glycol, Diazolidinyl Urea, Propylparaben, Methylparaben, Lanthanum Chloride, Magnesium Chloride, Sodium Citrate, Tetrasodium EDTA, Trimethoxycaprylylsilane, Glycoproteins, Glycosaminoglycans, Fragrance, Calcium Chloride." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately." ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warning - For external use only." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Safe Sea Sunscreen With Jellyfish Sting Protective SPF 15 OCTINOXATE, ZINC OXIDE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC WATER CYCLOMETHICONE MINERAL OIL SODIUM DICHLOROACETATE HYDROGENATED CASTOR OIL PROPYLENE GLYCOL DIAZOLIDINYL UREA PROPYLPARABEN METHYLPARABEN MAGNESIUM CHLORIDE SODIUM CITRATE EDETATE SODIUM TRIMETHOXYCAPRYLYLSILANE CALCIUM CHLORIDE" ], "description": [ "Description SAFE SEA Sunscreen SPF 15 With Jellyfish Sting Protective Lotion The world's only sunscreen lotion scientifically developed to help prevent the stings from most jellyfish*, Sea nettle, Sea lice (Seabathers eruption). Dermatologist tested. UVAandUVB protection For sensitive skin. Water resistant. Distributed by Nidaria Technology ltd. 420 Lexington Avenue Suite 2400 New York, New York 10170 Made in Israel. www.nidaria.com US Patents No. 6338837 / 6406709 / 6132747 NDC - 0654350115 7 13026 10115 5" ], "other_safety_information": [ "Other Information - Give particular attention to coverage of arms and legs. - In water infested by Sea Lice, Safe Sea should also be applied under the bathing suit. Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water, nor is it a guarantee against stings. - In case of sting do not use Safe Sea as a treatment - seek medical attention. * Tested against Sea nettle (Chrysaora), Atlantic Box jellyfish (Chiropsalmus) and Rhopilema. Date on file." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions - Adults and children six months of age and older. Apply Liberally to all exposed areas 10 minutes before sun or water exposure. - Ensure complete coverage. - Reapply after prolonged swimmimg and towel drying." ], "stop_use": [ "Stop use and ask a doctor if skin irritation or rash develops." ], "package_label_principal_display_panel": [ "SAFE SEA Sunscreen SPF 15 With Jellyfish Sting Protective Lotion", "SAFE SEA Sunscreen with JELLYFISH STING PROTECTIVE LOTION SPF 15 Helps Prevent Stings from Jellyfish and Sea Lice UVA, UVB, Water Resistant Clinically Tested 4 fl. oz. (118 ml)", "Product Package Outer Label A Safe Sea SPF 15 A", "Product Package Outer Label B Safe Sea SPF 15 B" ], "indications_and_usage": [ "Uses - Helps prevent sunburn. - Sun Protection Factor 15. - Retains SPF after 80 minutes of activity in the water or perspiring." ], "set_id": "045ded38-5d0a-45b3-951f-a58ae3cf5516", "id": "fdb6b8cf-f655-47b6-8052-623a40d2ff2a", "active_ingredient": [ "Active Ingredients Active Ingredients Purpose Octinoxate 7.5 %, Zinc Oxide 2 %.............................Sunscreen" ] }, { "effective_time": "20120523", "inactive_ingredient": [ "Inactive ingredients cetyl alcohol, glyceryl monostearate and PEG-100 stearate blend, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, trolamine and inert propellants: isobutane and propane." ], "purpose": [ "Purpose Local Anesthetic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not exceed the recommended daily dosage unless directed by a physician. If condition worsens or does not improve within 7 days, consult a physician. In case of rectal bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Do not insert any part of the aerosol container into the rectum. Certain persons can develop allergic reactions to the ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Do not put this product into the rectum by using fingers or any mechanical device or applicator. Do not insert any part of the aerosol container into the rectum." ], "questions": [ "Questions? 1-888-317-0001" ], "spl_product_data_elements": [ "Pramoxine Hydrochloride pramoxine hydrochloride pramoxine hydrochloride pramoxine cetyl alcohol glyceryl monostearate methylparaben polyoxyl 40 stearate propylene glycol propylparaben water trolamine isobutane propane" ], "ask_doctor": [ "Do not exceed the recommended daily dosage unless directed by a physician. If condition worsens or does not improve within 7 days, consult a physician. In case of rectal bleeding, consult a physician promptly." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Place cap on container. Shake well before use. Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of proctofoam ® . Dispense proctofoam ® onto a clean tissue and apply externally to the affected area up to 5 times daily. Children under 12 years of age: consult a physician." ], "spl_unclassified_section": [ "Drug Facts", "ALAVEN ® PHARMACEUTICAL LLC Marietta, GA 30067, USA Rev. 08/08 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146" ], "stop_use": [ "Certain persons can develop allergic reactions to the ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a physician." ], "storage_and_handling": [ "Other information Store upright at controlled room temperature 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F). Do not refrigerate. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 15 g Carton NDC 54868-5865-0 STORE UPRIGHT proctofoam ® non- steroid (pramoxine hydrochloride 1%) hemorrhoidal foam For temporary relief of hemorrhoidal pain and itching For External Use Only 15 g net wt (0.53 oz) Principal Display Panel - 15 g Carton" ], "indications_and_usage": [ "Use for the temporary relief of pain and itching associated with hemorrhoids" ], "set_id": "0494f952-de65-49d8-a8a6-5ee5abd53619", "id": "026db3f4-9b34-4b2a-9f95-07ccce7c5685", "active_ingredient": [ "Active ingredient Pramoxine hydrochloride 1%" ] }, { "effective_time": "20140522", "inactive_ingredient": [ "Inactive ingredients: Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-10, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Glycerin, Lanolin, Lavender, Methylparaben, Mineral Oil, Paraffin, Petrolatum, Phenoxyethanol, Polyethylene Glycol 6000, Polysorbate 60, Propylparaben Sodium, Steareth-20, Trolamine, Vitamin A, Water" ], "purpose": [ "Purpose: Helps treat and prevent diaper rash Temporarily protects minor cuts scrapes and burns dries the oozing and weeping of poison ivy poison oak poison sumac" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings: For External Use Only." ], "when_using": [ "When using this product: Do not get in eyes." ], "spl_product_data_elements": [ "zinc oxide zinc oxide ZINC OXIDE ZINC OXIDE LANOLIN CETETH-10 MINERAL OIL PARAFFIN METHYLPARABEN PROPYLPARABEN SODIUM GLYCERIN PHENOXYETHANOL CETYL ALCOHOL STEARETH-20 POLYETHYLENE GLYCOL 6000 POLYSORBATE 60 CETOSTEARYL ALCOHOL CHOLECALCIFEROL VITAMIN A ALPHA-TOCOPHEROL ALOE VERA LEAF PETROLATUM TROLAMINE WATER" ], "openfda": {}, "version": "12", "dosage_and_administration": [ "Dosage and Administration: For skin protectant: Apply liberally as needed For diaper Rash: change wet and soiled diapers promptly allow to dry apply ointment liberally with each diaper change" ], "stop_use": [ "Stop use and ask a doctor if: condition worsens symptoms last more than 7 days or clear up and occur again in a few days, consult a physician" ], "spl_unclassified_section": [ "Other information: Store at room temperature avoid excessive heat contains color additives including FDC yellow # 5" ], "package_label_principal_display_panel": [ "Principal Display Panel Dynarex DynaShield Skin Protectant zinc_oxide.jpg zonc_oxide" ], "indications_and_usage": [ "Indications: For use as a general skin protectant and diaper rash." ], "set_id": "049b727b-6abd-410c-a5d8-7b9c0fdfdbeb", "id": "a137e963-1fa0-4772-a6a1-1d7a01bf1040", "active_ingredient": [ "Active Ingredient Purpose Zinc Oxide (1.8% w/w) Skin Protectant" ] }, { "effective_time": "20130722", "inactive_ingredient": [ "Inactive Ingredients Water, Sorbitol, Stearic Acid, Triethanolamine, Aluminum Starch Octenylsuccinate, Sorbitan Isostearate, VP/Eicosene Copolymer, Benzyl Alcohol, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away. May stain some fabrics." ], "warnings": [ "Warnings For External use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away. May stain some fabrics. Other Information protect this product from excessive heat and direct sun" ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "Rite Aid RENEWAL kids SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER SORBITOL OXYBENZONE OXYBENZONE STEARIC ACID BENZYL ALCOHOL TROLAMINE ALUMINUM STARCH OCTENYLSUCCINATE SORBITAN ISOSTEARATE TOCOPHEROL EDETATE DISODIUM METHYLPARABEN PROPYLPARABEN DIMETHICONE POLYGLYCERYL-3 DISTEARATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun protection measures. Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am - 2 pm Wear long sleeves shirts, pants, hats and sunglasses children under 6 month of age: Ask a doctor" ], "stop_use": [ "stop use and ask a doctor if rash occurs." ], "package_label_principal_display_panel": [ "Principal Display Panel RITE AID RENEWAL kids SUNSCREEN LOTION BORAD SPECTRUM SPF 50 UVA/UVB Protection Water Resistant (80 Minutes) Non-Stinging RECOMMENDED SKIN CANCER FOUNDATION ACTIVE RECOMMENDED AS AN EFFECTIVE UVA/UVB SUNSCREEN 8 FL OZ (236 mL) ZRA025A0.jpg" ], "indications_and_usage": [ "Uses helps prevent sunburn if used as directed with other sun protection measures ( see Directions) decrease the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "04d0a26b-5004-435c-81ba-87847c1dd2d9", "id": "01a9a5e5-b1e8-4c5c-988c-6852dc0f80ca", "active_ingredient": [ "Active Ingredients Avobenzone 3.0 % Homosalate 13.0% Octisalate 5.0% Octocrylene 7.0% Oxybenzone 4.0%" ] }, { "effective_time": "20150724", "inactive_ingredient": [ "Inactive Ingredients Water (aqua), dimethyl isosorbide, disodium PEG-12 dimethicone sulfosuccinate, magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, sorbitol, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, polyethylene, cetyl esters, tridecyl trimellitate, anthemis nobilis flower extract, sodium hyaluronate, sodium PCA, propylene glycol, xanthan gum, oxidized polyethylene, imidazolidinyl urea, methylparaben , propylparaben, fragrance (parfum), ferric ammonium ferrocyanide." ], "purpose": [ "Purpose Acne treatment" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide Ask doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. keep away from lips and mouth. avoid unnecessary sun exposure and use a sunscreen. Stop use and ask a doctor if irritation becomes severe. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. keep away from lips and mouth. avoid unnecessary sun exposure and use a sunscreen." ], "spl_product_data_elements": [ "Guthy Renker Proactiv Solution Extra Strength Cleanser BENZOYL PEROXIDE BENZOYL PEROXIDE BENZOYL PEROXIDE WATER DIMETHYL ISOSORBIDE MAGNESIUM ALUMINUM SILICATE GLYCERYL MONOSTEARATE PEG-100 STEARATE SORBITOL TRIDECYL STEARATE NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE HIGH DENSITY POLYETHYLENE CETYL ESTERS WAX TRIDECYL TRIMELLITATE CHAMAEMELUM NOBILE FLOWER HYALURONATE SODIUM SODIUM PIDOLATE PROPYLENE GLYCOL XANTHAN GUM IMIDUREA METHYLPARABEN PROPYLPARABEN FERRIC AMMONIUM FERROCYANIDE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Use morning and night. Apply a small (dime-sized) amount to dampened skin and gently massage for 1 to 2 minutes. Rinse thoroughly with warm water. Pat dry. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside use a sunscreen." ], "spl_unclassified_section": [ "Drug Facts", "Distributed by Guthy-Renker® Palm Desert, CA 92260" ], "stop_use": [ "Stop use and ask a doctor if irritation becomes severe." ], "storage_and_handling": [ "Other information This product may bleach hair or dyed fabrics. Store at room temperature. Aviod storing at extreme temperatures (below 40° F and above 100 °F)." ], "do_not_use": [ "Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label Rodan & Fields p roactiv ® SOLUTION EXTRA STRENGTH FORMULA cleanser 1 benzoyl peroxide acne treatment 4 FL.OZ. 120 mL Principal Display Panel - 120 mL Bottle Label" ], "indications_and_usage": [ "Use for the management of acne." ], "set_id": "04e6dba9-66e9-441b-8956-2038935e7cf6", "id": "e11faf5a-afca-4517-9e57-384620d3225e", "ask_doctor_or_pharmacist": [ "Ask doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor." ], "active_ingredient": [ "Active Ingredient Benzoyl peroxide 7%" ] }, { "effective_time": "20120323", "inactive_ingredient": [ "Inactive ingredients Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Beeswax, Calamine, Carthamus Tinctorius Seed Oil, Cholecalciferol, Citric Acid, Citrus Aurantium Dulcis Peel Oil, Citrus Grandis Peel Oil, Citrus Tangerina Peel Oil, Glycerine, Glycine, Helianthus Annuus Seed Oil, Hydroxytyrosol, L-proline, L-taurine, Methylparaben, Modified Corn Starch, Methylsulfonymethane, N-acetyl-L-cysteine, Niacinamide, Olea Europaea Fruit Oil, PEG-8, Pyridoxine HCI, Retinyl Palmitate, Tocopherol, Vanillin, Water, White Petrolatum, Zea Mays Oil." ], "purpose": [ "Purpose Analgesic Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For External Use Only Do not use on deep or puncture wounds on animal bites on serious burns. When using this product do not get into eyes. Stop use and ask a doctor if condition worsens symptoms last for more than 7 days or clear up and occur again within a few days Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not get into eyes." ], "spl_product_data_elements": [ "REMEDY Calazime Skin Protectant zinc oxide, menthol MENTHOL MENTHOL ZINC OXIDE ZINC OXIDE ALOE VERA LEAF ASCORBIC ACID ASCORBYL PALMITATE YELLOW WAX ZINC OXIDE FERRIC OXIDE RED SAFFLOWER OIL CHOLECALCIFEROL CITRIC ACID MONOHYDRATE ORANGE OIL GLYCERIN GLYCINE SUNFLOWER OIL METHYLPARABEN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) DIMETHYL SULFONE ACETYLCYSTEINE NIACINAMIDE OLIVE OIL POLYETHYLENE GLYCOL 400 PYRIDOXINE HYDROCHLORIDE VITAMIN A PALMITATE .ALPHA.-TOCOPHEROL VANILLIN WATER PETROLATUM CORN OIL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Cleanse skin with Remedy's 4-IN-1 Cleansing lotion or 4-IN-1 Body Cleanser apply paste to area as needed for peri-G tubes, cleanse as above, apply thin layer and secure with drain sponge or product as directed." ], "stop_use": [ "Stop use and ask a doctor if condition worsens symptoms last for more than 7 days or clear up and occur again within a few days Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor." ], "storage_and_handling": [ "Other information Protect from freezing, Avoid excessive heat." ], "do_not_use": [ "Do not use on deep or puncture wounds on animal bites on serious burns." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Medline Remedy with Olivamine - Calazime MEDLINE N 53329-164-44 REMEDY WITH OLIVAMINE CALAZIME SKIN PROTECTANT PASTE WITH ZINC OXIDE Nourishes skin. Helps treat and prevent diaper rash, wet and cracked skin. NON-ALLERGENIC NON-SENSITIZING NET WT 4 oz (113 g) Medline Remedy with Olivamine - Calazime" ], "indications_and_usage": [ "Uses Helps treat and prevent diaper rash Protects from minor skin irritation associated with diaper rash caused from wetness, urine and/or stool." ], "set_id": "04e8d37a-c8a9-4b11-8b56-62a1110da94c", "id": "b5433b37-73c3-455d-9015-62864dae49b1", "active_ingredient": [ "Active ingredient Menthol 0.2% Zinc Oxide 20%" ] }, { "effective_time": "20110228", "inactive_ingredient": [ "Calcium Carbonate, Water, Glycerine, Hydrated Silica, Sodium Lauryl Sulphate, Silica, Cellulose gum, Flavour, Carvone, Sodium Saccharin, Methylparaben, Limonene" ], "purpose": [ "Purpose Anticavity" ], "keep_out_of_reach_of_children": [ "keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away." ], "warnings": [ "Warnings keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away." ], "questions": [ "Questions? call 718 256 9100 you may also report serious side effects to this phone number" ], "spl_product_data_elements": [ "Zohar Toothpaste Cool Mint SODIUM MONOFLUOROPHOSPHATE SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION CALCIUM CARBONATE WATER GLYCERIN HYDRATED SILICA SODIUM LAURYL SULFATE SILICON DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM CARVONE, (+/-)- SACCHARIN SODIUM METHYLPARABEN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions do not swallow supervise children as necessary until capable of using without supervision. adults and children 6 years of age and older Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. children 6 to 12 years instruct in good brushing and rinsing habits(to minimise swallowing) children under 6 years do not use unless directed by dentist or doctor" ], "package_label_principal_display_panel": [ "Principal Display Panel Zohar FLUORIDE TOOTHPASTE COOL MINT HELPS FIGHT TOOTH DECAY Net Wt. 4oz/75ml Zohar Fluoride Toothpaste Cool Mint" ], "indications_and_usage": [ "Uses Aids in the prevention of dental cavities" ], "set_id": "04f24771-fd67-434b-b57b-4324bb5006a0", "id": "0c56a265-60a1-4337-b245-99a631c63364", "active_ingredient": [ "Active Ingredients Sodium monofluorphosphate 1.15% (1500 ppm/ 0.15% w/v fluoride ion)" ], "dosage_and_administration_table": [ "
adults and children 6 years of age and older Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
children 6 to 12 years instruct in good brushing and rinsing habits(to minimise swallowing)
children under 6 years do not use unless directed by dentist or doctor
" ] }, { "effective_time": "20100528", "inactive_ingredient": [ "Inactive Ingredients Benzyl alcohol, carbomer 974P, FD and C green 5, Flavor, glycerin, Methylparaben, Polyethylene glycol, PEG 400, PEG 600, Sodium Saccharin" ], "purpose": [ "Purpose Oral anesthetic" ], "warnings": [ "Warnings Allergy Alert: do not use this pr9oduct if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other :caine\" anesthetics." ], "when_using": [ "When using this product Avoid contact with eyes Do not exceed recommended dosage Do not use for more than 7 days unless directed by a doctor/dentist" ], "spl_product_data_elements": [ "Oral B Instant Pain Relief benzocaine Benzocaine benzocaine benzyl alcohol Glycerin methylparaben Polyethylene glycol Polyethylene glycol 400 Polyethylene Glycol 600 Saccharin Sodium CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) Scope Original Mint Flavor FD and C Green 5" ], "openfda": {}, "version": "3", "spl_unclassified_section": [ "Uses Temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures", "Directions: Remove cap-, squeeze gel onto applicator Adults and children 2 years of age and older, apply to the affected area 4 times per day or as directed by a doctor/dentist Children under 2 years of age; consult a doctor/dentist For Denture wearers Remove Dentures Apply thin layer to affected area Do not reinsert dental work until irritation is relieved Rinse mouth well before reinserting dentures", "Other information: Store between 20 0 to 25 0 C (68 0 to 77 0 F) Do not refrigerate Do not purcahse if package has been opened" ], "stop_use": [ "Stop use and ask a doctor if: sore mouth symptoms do not improve in 7 days Irritation, pain or redness persist or worsens Swelling, pain or fever develops" ], "package_label_principal_display_panel": [ "Oral B Pain gel label MM27 oral B tooth pain gel label", "Oral B pain gel blister MM28 oral B tooth pain gel blister", "Oral B shipper label MM29 Oral B shipper label" ], "set_id": "04f67d13-d0fa-409c-94bb-0f0e780bc812", "id": "0ef7f255-aca0-4237-aa21-267780aca1d1", "active_ingredient": [ "Active Ingredient Benzocaine 20% Purpose Oral anesthetic" ] }, { "effective_time": "20090827", "drug_interactions": [ "Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction.", "Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly.", "CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.", "Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose.", "Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution.", "Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly." ], "geriatric_use": [ "Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "abuse": [ "Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence." ], "precautions": [ "PRECAUTIONS Animal reproduction studies have not been conducted with the drug combination-promethazine and codeine. It is not known whether this drug combination can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Promethazine hydrochloride and codeine phosphate should be given to a pregnant woman only if clearly needed. General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ). Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services). Drug Interactions: Codeine: In patients receiving MAO inhibitors, an initial small test dose is advisable to allow observation of any excessive narcotic effects or MAOI interaction. Promethazine: CNS Depressants – Promethazine may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine. Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames. Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown. Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS – General - Ultra-Rapid Metabolizers of Codeine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman. Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see Warnings-Use in Pediatric Patients ). Geriatric Use: Clinical studies of promethazine hydrochloride and codeine phosphate syrup did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine with codeine syrup and observed closely." ], "description": [ "DESCRIPTION Each 5 mL (one teaspoonful), for oral administration contains: Promethazine hydrochloride 6.25 mg; codeine phosphate 10 mg. Alcohol 7%. Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine.", "Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy; it is classified pharmacologically as a narcotic analgesic. Codeine phosphate may be chemically designated as 7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. It has a molecular weight of 406.37, a molecular formula of C 18 H 21 NO 3 •H 3 PO 4 •½H 2 O, and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C 17 H 20 N 2 S•HCI, and the following structural formula: This is an image of the structural formula of Codeine Phosphate. This is an image of the structural formula of Promethazine." ], "labor_and_delivery": [ "Labor And Delivery: Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE ). Limited data suggest that use of promethazine hydrochloride during labor and delivery does not have an appreciable effect on the duration of labor or delivery and does not increase the risk of need for intervention in the newborn. The effect of promethazine and/or codeine on the later growth and development of the newborn is unknown." ], "general_precautions": [ "General: Narcotic analgesics, including codeine, should be administered with caution and the initial dose reduced in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal impairment, fever, hypothyroidism, Addison's disease, ulcerative colitis, prostatic hypertrophy, in patients with recent gastrointestinal or urinary tract surgery, and in the very young or elderly or debilitated patients. Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. Promethazine should be used cautiously in persons with cardiovascular disease or with impairment of liver function. Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers ).", "Ultra-Rapid Metabolizers of Codeine Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose (see PRECAUTIONS - Nursing Mothers )." ], "storage_and_handling": [ "Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP." ], "indications_and_usage": [ "INDICATIONS AND USAGE Promethazine with codeine syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold." ], "dependence": [ "Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "set_id": "0505fe62-ac59-475e-8c94-1933398be580", "id": "30004e84-7a7b-46ac-b6fe-bd1835dd9fcf", "teratogenic_effects": [ "Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.", "Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known.", "Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." ], "pediatric_use": [ "Use In Pediatric Patients The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. The association does not directly relate to individualized weight-based dosing, which might otherwise permit safe administration. Excessively large dosages of antihistamines, including promethazine hydrochloride, in pediatric patients may cause sudden death (see OVERDOSAGE ). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.", "Pediatric Use: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population ( see WARNINGS – Box Warning and Use In Pediatric Patients ). The combination of promethazine hydrochloride and codeine phosphate should be used with caution in pediatric patients 6 years and older (see Warnings-Use in Pediatric Patients )." ], "inactive_ingredient": [ "Inactive Ingredients: Ascorbic acid, citric acid, FD&C blue #1, FD&C red #3, grape blend flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose." ], "contraindications": [ "CONTRAINDICATIONS The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. Codeine is contraindicated in patients with a known hypersensitivity to the drug. Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma." ], "drug_abuse_and_dependence": [ "DRUG ABUSE AND DEPENDENCE Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance. Abuse: Codeine is known to be subject to abuse; however, the abuse potential of oral codeine appears to be quite low. Even parenteral codeine does not appear to offer the psychic effects sought by addicts to the same degree as heroin or morphine. However, codeine must be administered only under close supervision to patients with a history of drug abuse or dependence. Dependence: Psychological dependence, physical dependence, and tolerance are known to occur with codeine." ], "warnings": [ "WARNINGS WARNING: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients. Codeine: Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients. Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Codeine: Dosage of codeine SHOULD NOT BE INCREASED if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease. Codeine may cause or aggravate constipation. Respiratory depression leading to arrest, coma, and death has occurred with the use of codeine antitussives in young children, particularly in the under-one-year infants whose ability to deactivate the drug is not fully developed. Administration of codeine may be accompanied by histamine release and should be used with caution in atopic children. Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries. Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function. Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Head Injury And Increased Intracranial Pressure: The respiratory-depressant effects of narcotic analgesics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Narcotics may produce adverse reactions which may obscure the clinical course of patients with head injuries.", "Asthma And Other Respiratory Conditions: Narcotic analgesics or cough suppressants, including codeine, should not be used in asthmatic patients (see CONTRAINDICATIONS ). Nor should they be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient's respiratory function.", "Hypotensive Effect: Codeine may produce orthostatic hypotension in ambulatory patients.", "Promethazine: CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ). Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold. Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "CNS Depression – Promethazine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS - Information For Patients and Drug Interactions ).", "Respiratory Depression – Promethazine may lead to potentially fatal respiratory depression. Use of promethazine in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.", "Lower Seizure Threshold – Promethazine may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.", "Bone-Marrow Depression – Promethazine should be used with caution in patients with bone marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents.", "Neuroleptic Malignant Syndrome – A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.", "Other Considerations Administration of promethazine has been associated with reported cholestatic jaundice." ], "pregnancy": [ "Pregnancy: Teratogenic Effects - Pregnancy Category C. Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120-mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100-mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring. There are no studies in humans, and the significance of these findings to humans, if any, is not known. Promethazine: Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine in pregnant women. Promethazine and codeine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "nursing_mothers": [ "Nursing Mothers: It is not known whether promethazine is excreted in human milk. Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants. The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1–10% in Caucasians, 3% in African Americans, and 16–28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine-containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding (see PRECAUTIONS – General - Ultra-Rapid Metabolizers of Codeine ). Caution should be exercised when promethazine with codeine syrup is administered to a nursing woman." ], "spl_product_data_elements": [ "Promethazine with Codeine Promethazine Hydrochloride and Codeine Phosphate CODEINE PHOSPHATE CODEINE PROMETHAZINE HYDROCHLORIDE PROMETHAZINE ALCOHOL ASCORBIC ACID CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 3 MENTHOL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE grape blend flavor" ], "boxed_warning": [ "WARNING: The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age. Concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with use of promethazine hydrochloride in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride have resulted in respiratory depression in these patients." ], "drug_and_or_laboratory_test_interactions": [ "Drug/Laboratory Test Interactions: Because narcotic analgesics may increase biliary tract pressure with resultant increases in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after a narcotic analgesic has been given. The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride. Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine.", "Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or false-positive interpretations.", "Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine." ], "openfda": {}, "controlled_substance": [ "Controlled Substance: Promethazine with codeine syrup is a Schedule V Controlled Substance." ], "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population. It is important that promethazine with codeine syrup is measured with an accurate measuring device (see PRECAUTIONS-Information For Patients ). A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. The average effective dose for adults and children 12 years of age and over is: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours. The average effective dose for children 6 years to under 12 years of age is 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours." ], "adverse_reactions": [ "ADVERSE REACTIONS Codeine: Nervous System – CNS depression, particularly respiratory depression, and to a lesser extent circulatory depression; light-headedness, dizziness, sedation, euphoria, dysphoria, headache, transient hallucination, disorientation, visual disturbances, and convulsions. Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, orthostatic hypotension (common to narcotic analgesics). Gastrointestinal – Nausea, vomiting, constipation, and biliary tract spasm. Patients with chronic ulcerative colitis may experience increased colonic motility; in patients with acute ulcerative colitis, toxic dilation has been reported. Genitourinary – Oliguria, urinary retention; antidiuretic effect has been reported (common to narcotic analgesics). Allergic – Infrequent pruritus, giant urticaria, angioneurotic edema, and laryngeal edema. Other – Flushing of the face, sweating and pruritus (due to opiate-induced histamine release); weakness. Promethazine: Central Nervous System – Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal – Dry mouth, nausea, vomiting, jaundice. Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS - Promethazine; Respiratory Depression .) Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. (See WARNINGS - Promethazine; Neuroleptic Malignant Syndrome .) Paradoxical Reactions – Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCI. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients." ], "spl_unclassified_section": [ "CV Rx only", "Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8181652 R1/09-R4 Relabeling of \"Additional Barcode label\" by: Physicians Total Care, Inc. Tulsa, OK 74146" ], "how_supplied": [ "HOW SUPPLIED Promethazine with Codeine Syrup, a clear purple syrup with odor of grape menthol, contains promethazine hydrochloride 6.25 mg/5 mL, codeine phosphate 10 mg/5 mL and alcohol 7 percent, and is available in: 4 fluid ounce (118 mL) NDC 54868-1029-1 , 8 fluid ounce (237 mL) NDC 54868-1029-0 . and pint (473 mL) NDC 54868-1029-2 ." ], "information_for_patients": [ "Information For Patients: Patients should be advised to measure promethazine with codeine syrup with an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when a half a teaspoon is measured. A pharmacist can recommend an appropriate measuring device and can provide instructions for measuring the correct dose. Promethazine and codeine may cause marked drowsiness or may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. Ambulatory patients should be told to avoid engaging in such activities until it is known that they do not become drowsy or dizzy from promethazine and codeine therapy. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. The concomitant use of alcohol or other central-nervous-system depressants, such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers may enhance impairment and should be avoided or their dosage reduced (see WARNINGS -CNS Depression and PRECAUTIONS-Drug Interactions ). Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. Codeine, like other narcotic analgesics, may produce orthostatic hypotension in some ambulatory patients. Patients should be cautioned accordingly. Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services)." ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Promethazine with Codeine Syrup This is an image of the label for Promethazine with Codiene Syrup." ], "clinical_pharmacology": [ "CLINICAL PHARMACOLOGY Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours. Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.", "Codeine: Narcotic analgesics, including codeine, exert their primary effects on the central nervous system and gastrointestinal tract. The analgesic effects of codeine are due to its central action; however, the precise sites of action have not been determined, and the mechanisms involved appear to be quite complex. Codeine resembles morphine both structurally and pharmacologically, but its actions at the doses of codeine used therapeutically are milder, with less sedation, respiratory depression and gastrointestinal, urinary, and pupillary effects. Codeine produces an increase in biliary tract pressure, but less than morphine or meperidine. Codeine is less constipating than morphine. Codeine has good antitussive activity, although less than that of morphine at equal doses. It is used in preference to morphine, because side effects are infrequent at the usual antitussive dose of codeine. Codeine in oral therapeutic dosage does not usually exert major effects on the cardiovascular system. Narcotic analgesics may cause nausea and vomiting by stimulating the chemoreceptor trigger zone (CTZ); however, they also depress the vomiting center, so that subsequent doses are unlikely to produce vomiting. Nausea is minimal after usual oral doses of codeine. Narcotic analgesics cause histamine release, which appears to be responsible for wheals or urticaria sometimes seen at the site of injection on parenteral administration. Histamine release may also produce dilation of cutaneous blood vessels, with resultant flushing of the face and neck, pruritus, and sweating. Codeine and its salts are well absorbed following both oral and parenteral administration. Codeine is about ⅔ as effective orally as parenterally. Codeine is metabolized primarily in the liver by enzymes of the endoplasmic reticulum, where it undergoes O-demethylation, N-demethylation, and partial conjugation with glucuronic acid. The drug is excreted primarily in the urine, largely as inactive metabolites and small amounts of free and conjugated morphine. Negligible amounts of codeine and its metabolites are found in the feces. Following oral or subcutaneous administration of codeine, the onset of analgesia occurs within 15 to 30 minutes and lasts for four to six hours. The cough-depressing action, in animal studies, was observed to occur 15 minutes after oral administration of codeine, peak action at 45 to 60 minutes after ingestion. The duration of action, which is dose-dependent, usually did not exceed 3 hours.", "Promethazine: Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine." ], "carcinogenesis_and_mutagenesis_and_impairment_of_fertility": [ "Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term animal studies have not been performed to assess the carcinogenic potential of codeine or of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with these agents. Codeine has been reported to show no evidence of carcinogenicity or mutagenicity in a variety of test systems, including the micronucleus and sperm abnormality assays and the Salmonella assay. Promethazine was nonmutagenic in the Salmonella test system of Ames." ], "nonteratogenic_effects": [ "Nonteratogenic Effects - Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life. Promethazine administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn." ], "overdosage": [ "OVERDOSAGE Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates. Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur. Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful.", "Codeine: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. The triad of coma, pinpoint pupils, and respiratory depression is strongly suggestive of opiate poisoning. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. Promethazine is additive to the depressant effects of codeine. It is difficult to determine what constitutes a standard toxic or lethal dose. However, the lethal oral dose of codeine in an adult is reported to be in the range of 0.5 to 1.0 gram. Infants and children are believed to be relatively more sensitive to opiates on a body-weight basis. Elderly patients are also comparatively intolerant to opiates.", "Promethazine: Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms – dry mouth, fixed dilated pupils, flushing, as well as gastrointestinal symptoms may occur.", "Treatment: The treatment of overdosage with promethazine and codeine is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs including respiration, pulse, blood pressure, temperature, and EKG need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist, naloxone hydrochloride, may be administered when significant respiratory depression occurs with promethazine and codeine; any depressant effects of promethazine are not reversed with naloxone. Diazepam may be used to control convulsions. Avoid analeptics, which may cause convulsions. Acidosis and electrolyte losses should be corrected. A rise in temperature or pulmonary complications may signal the need for institution of antibiotic therapy. Severe hypotension usually responds to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED, since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Limited experience with dialysis indicates that it is not helpful." ] }, { "effective_time": "20151012", "inactive_ingredient": [ "Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate" ], "purpose": [ "Purpose Stimulant Laxative" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Do not use if you cannot swallow without chewing Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not use within 1 hour after taking an antacid or milk do not chew or crush tablet(s) you may have stomach discomfort, faintness or cramps" ], "spl_product_data_elements": [ "Gentle Laxative Bisacodyl BISACODYL BISACODYL ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES FERROSOFERRIC OXIDE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 5" ], "ask_doctor": [ "Ask a doctor before use if you have a sudden change in bowel habits that lasts more than 2 weeks stomach pain, nausea or vomiting" ], "openfda": {}, "version": "10", "dosage_and_administration": [ "Directions take with a glass of water adults and children 12 years and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a laxative for more than 1 week" ], "spl_unclassified_section": [ "Other information store at controlled room temperature 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number" ], "do_not_use": [ "Do not use if you cannot swallow without chewing" ], "package_label_principal_display_panel": [ "Principal Display Panel For Temporary Relief of Occasional Constipation Compare to the Active Ingredient of Ducolax®* Gentle Laxative Bisacodyl Stimulant Laxative 25 Tablets 5 mg each TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *DISTRIBUTED BY NASH FINCH COMPANY ©2004, 1996 NFC BRANDS 7600 FRANCE AVE S, MPLS, MN 55435 www.ourfamilyfoods.com NF00000 50844 REV0510B32765 Our Family 44-327-56 Product Label" ], "indications_and_usage": [ "Use(s) relieves occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours" ], "set_id": "050780d6-b1bd-4717-b517-527b86bb9dfa", "id": "aa329d94-d60c-4a9b-aebd-d707ba6bedb1", "active_ingredient": [ "Active ingredient Bisacodyl 5 mg" ], "dosage_and_administration_table": [ "
adults and children 12 years and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age take 1 tablet in a single daily dose
children under 6 years of age ask a doctor
" ] }, { "effective_time": "20140506", "inactive_ingredient": [ "Inactive ingredients corn starch, methylparaben, propylparaben, shark liver oil" ], "purpose": [ "Purpose Protectant Vasoconstrictor" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "warnings": [ "Warnings For rectal use onl y Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)" ], "when_using": [ "When using this product do not exceed the recommended daily dosage unless directed by a doctor" ], "questions": [ "Questions or comments? 1-888-423-0139" ], "spl_product_data_elements": [ "topcare hemorrhoidal cocoa butter, phenylephrine hcl COCOA BUTTER COCOA BUTTER PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN METHYLPARABEN PROPYLPARABEN SHARK LIVER OIL" ], "ask_doctor": [ "Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product. • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows: • hold suppository with rounded end up • see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down” • slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository • remove exposed suppository from wrapper • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement • children under 12 years of age: ask a doctor" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "stop_use": [ "Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days" ], "storage_and_handling": [ "Other information • store at 20-25°C (68-77°F)" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel NIGHTTIME RELIEF Hemorrhoidal Suppositories REDUCES INTERNAL SWELLING. SOOTHES AND PROTECTS. Prompt soothing relief from painful burning, itching and discomfort Shrinks swollen hemorrhoidal tissue Protects irritated tissue E-Z OPEN WRAPPER COMPARE TO PREPARATION H® HEMORRHOIDAL SUPPOSITORIES active ingredients Hemorrhoidal Suppositories Carton Image 1 Hemorrhoidal Suppositories Carton Image 2" ], "indications_and_usage": [ "Uses • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily relieves burning and shrinks hemorrhoidal tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful" ], "set_id": "05108c74-c244-44d1-96c7-4d0dbec49e99", "id": "a6a93ee5-df35-45ea-b570-e236ae065167", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression" ], "active_ingredient": [ "Active ingredient (in each suppository) Cocoa butter 85.39% Phenylephrine HCl 0.25%" ] }, { "effective_time": "20100708", "inactive_ingredient": [ "Inactive Ingredients PEG-8, propylene glycol, flavor, benzyl alcohol, methylparaben, saccharin, red 40, yellow 10, blue 1" ], "purpose": [ "Use s - temporary relieves pain associated with: - canker sores - minor irritation or injury of mouth and gums - minor dental procedures - minor irritation of mouth and gums caused by dentures or orthodontic appliances also for the temporary relief of sore gums due to teething in children 2 years of age and older" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If more than is used for oral anesthetic is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, contact your doctor. Do not use - for more than directed - for more than 7 days, unless directed by a dentist or doctor - if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other \"caine\" anesthetics When using this product - avoid contact with the eyes - do not exceed recommended dosage Stop use and ask a doctor if: - sore mouth symptoms do not improve in 7 days - swelling, rash or fever develops - irritation, pain or redness persists or worsens Keep out of reach of children. If more then used for oral anesthetic is accidentally swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Rite Aid Liquid Anesthetic Oral Pain Relief BENZOCAINE BENZYL ALCOHOL D&C YELLOW NO. 10 FD&C RED NO. 40 SPEARMINT OIL PEPPERMINT OIL METHYLPARABEN POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL BENZOCAINE BENZOCAINE SACCHARIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Adults and children 2 years of age and older - apply to the affected area - allow to remain in place at least 1 minute and then spit out - use up to four times a day or as directed by a dentist or doctor For teething apply to affected area not more than 4 times dialy, or as directed by a dentist or doctor Children under 2 years of age consult a dentist or doctor Children under 12 years of age should be supervised in the use of this product" ], "package_label_principal_display_panel": [ "c" ], "indications_and_usage": [ "Use s - temporary relieves pain associated with: - canker sores - minor irritation or injury of mouth and gums - minor dental procedures - minor irritation of mouth and gums caused by dentures or orthodontic appliances also for the temporary relief of sore gums due to teething in children 2 years of age and older" ], "set_id": "051e7752-965d-4961-b44a-c5036293a8eb", "id": "0273d979-c311-44e0-a2a7-16d1f27ff44e", "active_ingredient": [ "Active ingredient Purpose Benzocaine, 20%............................................Anesthetic" ] }, { "effective_time": "20140509", "inactive_ingredient": [ "INACTIVE INGREDIENTS Inactive Ingredients: Cetomicrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraben" ], "purpose": [ "Purpose For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis). For the treatment of superficial skin infections caused by Yeast (Candida Albicans). Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch." ], "keep_out_of_reach_of_children": [ "Keep Out Of Reach Of Children KEEP OUT Of REACH Of CHILDREN" ], "warnings": [ "Warnings Do not use: Do not use on children under 2 years of age unless directed by a doctor. Avoid contact with eyes. For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor. For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "Blossom Pharmaceuticals Antifungal antifungal CLOTRIMAZOLE CLOTRIMAZOLE CETETH-20 CETOSTEARYL ALCOHOL LIGHT MINERAL OIL METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER PETROLATUM" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Dosage and Administration Foe athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.If conditions persist longer, consult a doctor. This product is not effective on scalp or nails." ], "package_label_principal_display_panel": [ "Principal Display Panel Blossom Antifungal Cream Blossom Antifungal.jpg Blossom Antifungal" ], "indications_and_usage": [ "Indications and Usage Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily." ], "set_id": "05403332-6978-4dba-8b94-9b9502eeb1c1", "id": "0be9814f-595e-47da-ae39-4def3d8ab994", "active_ingredient": [ "Active Ingredient Active Ingredient Purpose Clotrimazole 1.0% Antifungal" ] }, { "effective_time": "20091207", "purpose": [ "PURPOSE protectant vasoconstrictor protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product do not exceed the recommended daily dosage." ], "questions": [ "" ], "pregnancy_or_breast_feeding": [ "If pregnant or breastfeeding ask a health professional before use." ], "storage_and_handling": [ "STORAGE Store in a cool place or at room temperature but not over 86° F." ], "indications_and_usage": [ "USES temporarily shrinks hemorrhoidal tissue temporarily relieves itching burning and discomfort associated with hemorrhoids" ], "set_id": "054fc819-6fbb-483e-89fb-71b58d094c9b", "id": "1065863d-fc11-4ca8-86f2-76ba8eba05c5", "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression." ], "active_ingredient": [ "ACTIVE INGREDIENTS Cocoa butter, 85.5% Phenylephrine HCI, 0.25% Shark liver oil, 3.0%" ], "inactive_ingredient": [ "INACTIVE INGREDIENTS methylparaben, propylparaben, starch" ], "warnings": [ "WARNINGS For rectal use only. Ask a doctor before use if you have heart disease thyroid disease difficulty in urination due to enlargement of the prostate gland high blood pressure diabetes Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage. Stop use and ask a doctor if you experience bleeding condition worsens or does not improve within 7 days. These may be signs of a serious condition. If pregnant or breastfeeding ask a health professional before use. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.", "" ], "spl_product_data_elements": [ "phenylephrine hydrochloride phenylephrine hydrochloride cocoa butter cocoa butter methylparaben propylparaben starch, corn phenylephrine hydrochloride phenylephrine shark liver oil shark liver oil" ], "ask_doctor": [ "Ask a doctor before use if you have heart disease thyroid disease difficulty in urination due to enlargement of the prostate gland high blood pressure diabetes" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before insertion of this product. Detach one suppository from strip Remove wrapper before inserting into rectum Hold suppository with rounded end up and insert tip of fingernail at end marked \"peel down\" Carefully peel film slowly and evenly down both sides to expose suppository Insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel movement Children under 12 years: ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if you experience bleeding condition worsens or does not improve within 7 days. These may be signs of a serious condition." ], "spl_unclassified_section": [ "" ], "do_not_use": [ "" ], "package_label_principal_display_panel": [ "PACKAGE INFORMATION NDC 50730-4812-0 Live Better Hemorrhoidal Suppositories PHENYLEPHRINE HCL 0.25% Temporary relief of burning, itching and discomfort Provides nighttime relief Shrinks swelling of irritated hemorrhoidal tissue Protects irritated tissue Easy to open 12 Suppositories DISTRIBUTED BY OMNIPOINT, INC. 2 PARAGON DRIVE, MONTVALE, NJ 07654 2009 ALL RIGHTS RESERVED Live Better products provide a simple way to look after yourself and your family. All of our products are crafted from high quality ingredients to exacting standards. Live Better is a great way to meet the health needs of your busy lifestyle. Live Better helps you be better. Live Better, for life. FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN. carton" ] }, { "effective_time": "20140509", "inactive_ingredient": [ "Inactive Ingredients Ozokerite, Mineral Oil, PEG-8, Lanolin, Microcrystalline Wax, Flavor, Paraffin Wax, Copernicia Cerifera (Carnauba) Wax, Sucralose, Aloe Barbadenis Leaf Extract, Tocopherol, Methylparaben, Propylparaben." ], "purpose": [ "Purpose Sunscreen, Sunscreen, Skin Protectant" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children If swallowed get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging. For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts." ], "spl_product_data_elements": [ "Zinka Watermelon SPF 15 Lip Balm Oxybenzone, Octinoxate, Petrolatum OCTINOXATE OCTINOXATE OXYBENZONE OXYBENZONE PETROLATUM PETROLATUM LIGHT MINERAL OIL MICROCRYSTALLINE WAX LANOLIN CERESIN PEG-8 STEARATE" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use." ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Zinka Watermelon SPF 15 Lip Balm" ], "indications_and_usage": [ "Uses Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips." ], "set_id": "05c2271c-88a5-4b9f-81c1-8fc17778005e", "id": "05c2271c-88a5-4b9f-81c1-8fc17778005e", "active_ingredient": [ "Active ingredient Octinoxate (7.5%), Oxybenzone (3.5%) Petrolatum (42%)" ] }, { "effective_time": "20140508", "inactive_ingredient": [ "Inactive ingredients acetylated lanolin alcohol, aloe barbadensis leaf juice, butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben USP, PEG-400 monolaurate, polysorbate 85" ], "purpose": [ "Purpose Topical analgesic Topical analgesic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center (1-800-222-1222) right away." ], "warnings": [ "Warnings For external use only. Avoid contact with eyes, mouth and mucous membranes. Contents flammable. Keep away from fire, open flame and heat. Contents under pressure. Do not puncture or incinerate can. Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics. Do not use excessive amounts of this product on broken, blistered, abraded skin or open wounds excessive amounts of this product over large areas of the body this product while smoking store at temperatures above 120 ◦ F When using this product: do not spray in eyes, on the face or in the mouth do not inhale intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal use only as directed Stop use and ask a doctor if: condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days itching, rash or irritation develops Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center (1-800-222-1222) right away." ], "when_using": [ "When using this product: do not spray in eyes, on the face or in the mouth do not inhale intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal use only as directed" ], "questions": [ "Questions? 1-800-443-4908 Mon.-Fri. 8 am to 8 pm EST Dermoplast.com ©2012 Distributed by Medtech Products Inc. Tarrytown, NY 10591, a Prestige Brands Company DOT 2P M5702 DP014502 UPC: 3-75137- 85 520 - 6" ], "spl_product_data_elements": [ "Dermoplast Pain Relieving Benzocaine and Menthol BENZOCAINE BENZOCAINE MENTHOL MENTHOL ACETYLATED LANOLIN ALCOHOLS ALOE VERA LEAF BUTANE CETYL ACETATE METHYLPARABEN POLYETHYLENE GLYCOL 400 POLYSORBATE 85" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions Adults and children 2 years and older Apply to affected area not more than 3 to 4 times Children under 2 years of age Consult doctor To use this product, hold can 6 to 12 inches away from affected area. Direct spray nozzle towards skin and press button to activate spray. To apply to face, first spray into palm of hand then touch hand to face." ], "spl_unclassified_section": [ "Dermoplast ® Anesthetic PAIN RELIEVING SPRAY Drug Facts", "Other information Caution: Avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration." ], "stop_use": [ "Stop use and ask a doctor if: condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days itching, rash or irritation develops" ], "do_not_use": [ "Do not use excessive amounts of this product on broken, blistered, abraded skin or open wounds excessive amounts of this product over large areas of the body this product while smoking store at temperatures above 120 ◦ F" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL Dermoplast Pain Relieving Spray Burn & Itch Net Wt 2.75 oz (78g) Dermoplast Pain Relieving Spray Burn & Itch Net Wt 2.75 oz (78g)" ], "indications_and_usage": [ "Uses For temporary relief of pain and itching associated with" ], "set_id": "0648c46c-a3db-4b82-971b-50a46098ac7e", "id": "1929e4be-3c97-4ecc-ad27-8462971189a3", "active_ingredient": [ "Active ingredients Benzocaine USP 20% Menthol USP 0.5%" ], "dosage_and_administration_table": [ "
Adults and children 2 years and older Apply to affected area not more than 3 to 4 times
Children under 2 years of age Consult doctor
" ] }, { "effective_time": "20121018", "inactive_ingredient": [ "Inactive ingredients USP water, mineral oil, petrolatum, alcohol, glyceryl stearate, PEG-100 stearate, paraffin, cetyl alcohol, lecithin, essential oils, imidazolidinyl urea, methylparaben, propylparaben, triethanolamine" ], "purpose": [ "Purpose Skin protectant" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product keep out of eyes. Do not use on deep wounds animal bites serious burns Stop use and ask a doctor if condition worsens symptoms lasts more than seven days or clear up and occur again within a few days Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes." ], "spl_product_data_elements": [ "nanocare Dimethicone Dimethicone Dimethicone water mineral oil petrolatum alcohol glyceryl monostearate PEG-100 stearate paraffin cetyl alcohol imidurea methylparaben propylparaben trolamine" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions apply to dry areas as needed children under 6 months: Ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Manufactured by: Dermazone Solutions, Inc. 2440 30th Avenue North St. Petersburg, FL 33713 USA Distributed by: Universal Sales & Marketing, Inc." ], "stop_use": [ "Stop use and ask a doctor if condition worsens symptoms lasts more than seven days or clear up and occur again within a few days" ], "do_not_use": [ "For external use only.", "Do not use on deep wounds animal bites serious burns" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 118 mL Jar Label nanocare for skin Penetrating Moisturizing Cream with sealing barrier 4.0 FL OZ (118 mL) PRINCIPAL DISPLAY PANEL - 118 mL Jar Label" ], "indications_and_usage": [ "Uses helps prevent and relieve chafed or cracked skin" ], "set_id": "064b0238-ea0b-4c3b-a032-863be27205ad", "id": "0f895e98-07ff-42c9-9e2a-17f6e328dae5", "active_ingredient": [ "Active ingredients Dimethicone 1.0%" ] }, { "effective_time": "20120706", "inactive_ingredient": [ "ALSO CONTAINS WATER, GLYCERIN, DIMETHICONE, NIACINAMIDE, PENTYLENE GLYCOL, CETYL ALCOHOL, STEARYL ALCOHOL, BEHENYL ALCOHOL, ALOE BARBADENSIS LEAF JUICE, PANTHENOL, TOCOPHERYL ACETATE, ISOHEXADECANE, POLYSORBATE 60, DIMETHICONOL, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, BENZYL ALCOHOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ASCORBIC ACID, STEARIC ACID, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, PEG-4 LAURATE, PEG-4 DILAURATE, IODOPROPYNYL BUTYLCARBAMATE, PEG-4, DISODIUM EDTA, PEG-100 STEARATE." ], "purpose": [ "complete" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN." ], "warnings": [ "WARNING FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR. KEEP OUT OF REACH OF CHILDREN." ], "when_using": [ "FOR EXTERNAL USE ONLY. NOT TO BE SWALLOWED. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR." ], "questions": [ "Questions? 1-800-285-5170 www.olay.com" ], "spl_product_data_elements": [ "Olay Complete All Day UV Moisturizer Sensitive Skin Octisalate, Avobenzone, Homosalate, and Octocrylene Octisalate Octisalate Avobenzone Avobenzone Homosalate Homosalate Octocrylene Octocrylene WATER GLYCERIN DIMETHICONE NIACINAMIDE PENTYLENE GLYCOL CETYL ALCOHOL STEARYL ALCOHOL DOCOSANOL ALOE VERA LEAF PANTHENOL .ALPHA.-TOCOPHEROL ACETATE ISOHEXADECANE POLYSORBATE 60 CETEARYL GLUCOSIDE CETOSTEARYL ALCOHOL BENZYL ALCOHOL ASCORBIC ACID STEARIC ACID METHYLPARABEN ETHYLPARABEN PROPYLPARABEN PEG-4 LAURATE PEG-4 DILAURATE IODOPROPYNYL BUTYLCARBAMATE POLYETHYLENE GLYCOL 200 EDETATE DISODIUM PEG-100 STEARATE" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions For all day SPF 15 protection, apply liberally on face and neck as often as necessary. Children under six months of age: consult a doctor." ], "spl_unclassified_section": [ "Dist. by PROCTER & GAMBLE, CINCINNATI, OH 45202" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 56 g Carton IMPROVED UVA PROTECTION OLAY ® complete all day UV moisture cream with vitamins E & B3 BROAD SPECTRUM SPF 15 UVA/UVB SUNSCREEN UV SKIN SHIELD SPF 15 NET WT 2.0 OZ (56 g) sensitive skin PRINCIPAL DISPLAY PANEL - 56 g Carton" ], "indications_and_usage": [ "Gives your skin essential Olay moisture, UV Skin Shield protection and vitamins for a lifetime of beautiful skin. All Day Moisture plus vitamin B3 for lasting hydration. UV Skin Shield SPF 15 to moisturize and provide broad spectrum UVA/UVB protection specifically designed for daily incidental sun exposure. Formula with Antioxidant vitamins C & E to promote and maintain a healthy-looking skin surface. Light, non-greasy formula for a barely-there feel. Dermatologically Tested Non-Comedogenic (won't clog pores) 100% Oil-Free • 100% PABA Free" ], "set_id": "0679fe1f-4847-4b25-8246-b12c7a48df23", "id": "bdd7c622-df00-407c-a355-578c4fd66e7e", "active_ingredient": [ "ACTIVE INGREDIENTS 5.0% OCTISALATE, 3.0% AVOBENZONE, 3.0% HOMOSALATE, 2.6% OCTOCRYLENE." ] }, { "effective_time": "20100609", "inactive_ingredient": [ "Inactive/Non Medicinal Ingredients: DIMETHICONE NEOPENTYL GLYCOL DICAPRATE PHENYL TRIMETHICONE POLYMETHYL METHACRYLATE OZOKERITE NYLON-12 MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE PHYTOL OLEA EUROPAEA (OLIVE) LEAF EXTRACT PYRUS MALUS (APPLE) ROOT EXTRACT GLYCINE SOJA (SOYBEAN) OIL SORBITAN SESQUIOLEATE PUNICA GRANATUM FRUIT JUICE RETINOXYTRIMETHYLSILANE TOCOPHERYL ACETATE RETINYL PALMITATE ASCORBYL PALMITATE TOCOPHEROL BARIUM SULFATE WATER/EAU TRIETHOXYCAPRYLYLSILANE METHICONE METHYLPARABEN MAY CONTAIN: TITANIUM DIOXIDE/CI 77891 MICA/CI 77019 IRON OXIDES" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "WARNINGS: For external use only. When using this product, keep out of eyes. If contact occurs, rinse thoroughly with water to remove. Stop use and ask a health care practitioner if rash or irritation develops or lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product, keep out of eyes. If contact occurs, rinse thoroughly with water to remove." ], "spl_product_data_elements": [ "Healthy Makeup Cream-to-Powder Foundation TITANIUM DIOXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE DIMETHICONE PHENYL TRIMETHICONE SORBITAN SESQUIOLEATE ASCORBYL PALMITATE BARIUM SULFATE WATER METHYLPARABEN TITANIUM DIOXIDE MICA" ], "ask_doctor": [ "Stop use and ask a health care practitioner if rash or irritation develops or lasts." ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions: Apply evenly before sun exposure as needed. Children under 6 months of age: Ask a healthcare practitioner." ], "package_label_principal_display_panel": [ "image of PDP image of carton image of carton image of carton" ], "indications_and_usage": [ "Uses: Helps prevent sunburn." ], "set_id": "067a3ee4-6090-4de8-92f3-e1083f426794", "id": "e7e7899a-29af-4410-bfef-a4239477be10", "active_ingredient": [ "Active/Medicinal Ingredient: TITANIUM DIOXIDE 8.5%" ] }, { "effective_time": "20150710", "inactive_ingredient": [ "Inactive ingredients Aqua(Water), Caprylyl methicone, Phenyl trimethicone, Boron nitride, PEG-9 dimethicone, Talc, Mica, Disteardimonium hectorite, Butylene glycol, Bis-isobutyl PEG/PPG-10-7 dimethicone crosspolymer,Trimethylsiloxysilicate, Magnesium sulfate, Phenoxyethanol, Polypropylsilsesquioxane, Triethyl citrate, Panthenol,Tocopheryl acetate, Methylparaben, Aluminum hydroxide, Ethylparaben, Stearic acid, Triethoxycaprylylsilane, PEG/PPG dimethylallylether, Sodium hyaluronate, Tetrasodium EDTA, Isopropyl palmitate, Lecithin, BHT, Tocopherol, , CI 77492(Iron oxides), CI 77891(Titanium dioxide) CI 77491(Iron oxides)CI 77499(Iron oxides)" ], "purpose": [ "Uses Uses - helps prevent sunburn" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "spl_product_data_elements": [ "No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 Deeply Beige Octinoxate Octinoxate OCTINOXATE WATER CAPRYLYL TRIMETHICONE PEG-9 DIMETHICONE (400 CST) BORON NITRIDE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) TALC MICA LECITHIN, SOYBEAN DISTEARDIMONIUM HECTORITE BUTYLENE GLYCOL MAGNESIUM SULFATE PHENOXYETHANOL TRIETHYL CITRATE .ALPHA.-TOCOPHEROL ACETATE PHENYL TRIMETHICONE METHYLPARABEN ETHYLPARABEN TRIETHOXYCAPRYLYLSILANE HYALURONATE SODIUM TOCOPHEROL PANTHENOL ALUMINUM HYDROXIDE STEARIC ACID ISOPROPYL PALMITATE FERRIC OXIDE YELLOW TITANIUM DIOXIDE FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "description": [ "Description Long lasting foundation for a naturally flawless complexion with super-staying power. This comfortable foundation feels lightweight and breathable and gives an even-toned beautifully smooth complexion that looks fresh all day long. Stay Perfect: look great, no matter what. Fragrance free,with SPF 15 and Vitamin E to protect and care for your skin. Non pore blocking. For Best Results: Shake before use. Blend smoothly and evenly with your fingers or a sponge, working downwards and outwards from the centre of your face. Hypoallergenic: Because all skin can have sensitive moments all our foundation products are hypo-allergenic so they are kind to even the most sensitive skin.", "Description Non stop complexion perfection All day wear" ], "warnings_and_cautions": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove", "Warnings warning: Avoid contact with eyes. If product gets into the eyes, rinse well with water immediately." ], "ask_doctor": [ "Ask a doctor Stop use and ask a doctor if rash occurs." ], "openfda": {}, "version": "1", "storage_and_handling": [ "Other information Protect the product in this container from excessive heat and direct sun" ], "information_for_patients": [ "Information The Boots Company PLC Nottingham England NG2 3AA Dist. by Boots Retail USa Inc. Norwalk CT 06851 USA Made in France www.boots.com", "Information The Boots Company PLC Nottingham England NG2 3AA. Dist. by Boots Retail USA Inc. Norwalk CT 06851 USA Made in france www.boots.com" ], "package_label_principal_display_panel": [ "Foundation carton No7StayPerfectFoundation" ], "indications_and_usage": [ "Directions Directions for suncreen use apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 monhts of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses" ], "set_id": "069497d7-5e54-4aa8-983c-d0118bebd2c1", "id": "f7624f52-7215-45a8-9d9c-8b544b9dae34", "active_ingredient": [ "Carton Active Ingredients Section Active Ingredients Octinoxate 5% Titanium dioxide 1.62%", "Jar label No7 Stay Perfect Foundation Sunscreen Broad Spectrum SPF 15 30ml e 1 US Fl.Oz. Active ingredients: Octinoxate 5.0% Titanium dioxide 1.62%" ] }, { "effective_time": "20110616", "inactive_ingredient": [ "OTHER INGREDIENTS: AQUA, TRIBEHENIN PEG-20 ESTERS, OCTYLDODECYL MYRISTATE, HYDROGENATED POLYDECENE, SIMMONDSIA CHINENSIS OIL, METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL, GLYCERIN, C12-15 ALKYLBENZOATE, CETEARYL ALCOHOL, DECYL GLUCOSIDE, TOPHENYL ACETATE, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, ALUMINIUM OXIDE, DISODIUM EDTA, PROPYLENE GLYCOL, XANTYAN GUM, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN." ], "instructions_for_use": [ "Directions: Gently massage into the skin of the face, neck, decolletage, and hands 30 minutes before sun exposure." ], "warnings": [ "Warnings: For external use only. Keep out of reach of children. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear." ], "spl_product_data_elements": [ "DESPIGMEN PROTECTIVE 25 OCTINOXATE, TITANIUM DIOXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM WATER TRIBEHENIN PEG-20 ESTERS ABETIMUS SODIUM JOJOBA OIL BISOCTRIZOLE GLYCERIN DODECYL BENZOATE ALPHA-TOCOPHEROL ALUMINUM STEARATE HYDROXYSTEARIC ACID ALUMINUM OXIDE EDETATE DISODIUM PROPYLENE GLYCOL XANTHAN GUM PHENOXYETHANOL METHYLPARABEN BUTYLPARABEN ETHYLPARABEN PROPYLPARABEN" ], "description": [ "Protector that provides the latest in scientific cosmetics to prevent dark spots, protecting the skin from sun damage and aging. Protection against UVA light is due to its state-of-the art \"organo-mineral\" solar filter. Protection against UVB light occurs by a highly efficient inorganic filter. Perfectly protected, the skin appear uniform, luminous, and free from shine." ], "openfda": {}, "version": "4", "package_label_principal_display_panel": [ "Image of Carton" ], "set_id": "06be9a64-bd9d-4060-92e5-1dd008047c3b", "id": "2d837941-c926-4706-b5c1-fe44ab27d103", "active_ingredient": [ "ACTIVE INGREDIENTS: OCTINOXATE 6% - sunscreen TITANIUM DIOXIDE 1.75% - sunscreen" ] }, { "effective_time": "20091228", "inactive_ingredient": [ "Inactive ingredients corn starch, FD&C red No. 3, flavor, glycerin, microcrystalline cellulose, purified water, sodium carboxymethyl cellulose, sodium methylparaben, sorbitol, sugar, xanthan gum" ], "purpose": [ "Active ingredients (in each 5g = 1 dose) Purpose Calcium Carbonate 750mg Antacid Magnesium Hydroxide 135mg Antacid" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "warnings": [ "Warnings Ask a doctor before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product Do not take more than 10 doses (50 grams) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor You may experience a laxative effect Stop use and ask doctor if Symptoms last more than two weeks Keep out of reach of children." ], "when_using": [ "When using this product Do not take more than 10 doses (50 grams) in a 24-hour period, or use the maximum dosage for more than two weeks, except under the advice and supervision of a doctor You may experience a laxative effect" ], "questions": [ "Questions? Comments? Call 877-942-2626 toll-free." ], "spl_product_data_elements": [ "Ultra Xcid Antacid calcium carbonate and magnesium hydroxide calcium carbonate calcium magnesium hydroxide magnesium" ], "ask_doctor": [ "Ask a doctor before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Tear open and squeeze. Squeeze out one to two doses (5 to 10 grams). Take between meals, at bedtime, or as directed by a doctor. Children under 12 years of age, ask a doctor." ], "spl_unclassified_section": [ "Drug Facts" ], "stop_use": [ "Stop use and ask doctor if Symptoms last more than two weeks" ], "storage_and_handling": [ "Other information Each dose contains: calcium 300 mg, magnesium 56 mg. Do not use if sealed packet was open or damaged. Store at room temperature 15° C-29° C (59° F-84° F). Do not freeze." ], "active_ingredient_table": [ "
Active ingredients (in each 5g = 1 dose) Purpose
Calcium Carbonate 750mg Antacid
Magnesium Hydroxide 135mg Antacid
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 10 g Pouch FREE SAMPLE TEAR HERE Not a Liquid or a Tablet. It's ... NDC 62750-024-15 2 Doses NEW! Ultra XCID ™ ANTACID FAST-ACTING RELIEF Creamy, Non-Chalky Taste Strawberry Cream Soother From the makers of ZICAM ® Net Wt 0.35 oz (10 g) Principal Display Panel - 10 g Pouch" ], "indications_and_usage": [ "Uses For the relief of: Acid indigestion Heartburn Sour stomach Upset stomach associated with these symptoms Overindulgence in food and drink" ], "set_id": "06c2cd73-09f4-4d70-991c-5bf898addfb3", "id": "f78a525b-0a51-455d-8393-ce8230028369", "purpose_table": [ "
Active ingredients (in each 5g = 1 dose) Purpose
Calcium Carbonate 750mg Antacid
Magnesium Hydroxide 135mg Antacid
" ], "active_ingredient": [ "Active ingredients (in each 5g = 1 dose) Purpose Calcium Carbonate 750mg Antacid Magnesium Hydroxide 135mg Antacid" ] }, { "effective_time": "20130708", "inactive_ingredient": [ "Inactive Ingredients Water, C12-15 Alkyl Benzoate, Dimethicone, Glycine Soja (Soybean) Seed Extract, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Ethylene/Acrylic Acid Copolymer, Glycerin, Panthenol, Phenyl Trimethicone, Silica, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Cetearyl Glucoside, Methylparaben, Steareth-2, Polyacrylate-13, Behenyl Alcohol, Titanium Dioxide, Steareth-21, Mica, Polymethyl Methacrylate, Disodium EDTA, Polyisobutene, Arachidyl Glucoside, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Boron Nitride, Polysorbate 20, Propylparaben, Ethylparaben, Benzalkonium Chloride, Phenoxyethanol, Fragrance" ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or Comments? Call toll-free 866-638-4636 or 215-273-8755 (collect) or visit www.neutrogenamen.com" ], "spl_product_data_elements": [ "Neutrogena Men Sensitive Skin Oil Free Moisture Sunscreen Broad Spectrum SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone Avobenzone Avobenzone Homosalate Homosalate Octisalate Octisalate Octocrylene Octocrylene Oxybenzone Oxybenzone WATER ALKYL (C12-15) BENZOATE DIMETHICONE SOYBEAN CETOSTEARYL ALCOHOL DIETHYLHEXYL 2,6-NAPHTHALATE GLYCERIN PANTHENOL PHENYL TRIMETHICONE SILICON DIOXIDE ALUMINUM STARCH OCTENYLSUCCINATE ARACHIDYL ALCOHOL CETEARYL GLUCOSIDE METHYLPARABEN STEARETH-2 DOCOSANOL TITANIUM DIOXIDE STEARETH-21 MICA EDETATE DISODIUM ARACHIDYL GLUCOSIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) BORON NITRIDE POLYSORBATE 20 PROPYLPARABEN ETHYLPARABEN BENZALKONIUM CHLORIDE PHENOXYETHANOL" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions Apply liberally to face and neck every morning or when skin needs extra moisture. For sunscreen use: apply generously 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Neutrogena Corporation L.A., CA 90045" ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "storage_and_handling": [ "Other Information protect this product from excessive heat and direct sun" ], "do_not_use": [ "Do not use on damaged or broken skin" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 50mL Bottle Carton Neutrogena ® MEN SENSITIVE SKIN Oil- Free Moisture with sunscreen broad spectrum SPF 30 helioplex ® Soothes and hydrates with advanced UVA/UVB protection 1.7 FL OZ [50mL] PRINCIPAL DISPLAY PANEL - 50mL Bottle Carton" ], "indications_and_usage": [ "Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "06f03ece-cd05-440d-99a2-8d94839269f9", "id": "cabbdca9-d389-417f-8d2e-9f297ee7b84f", "active_ingredient": [ "Active ingredients Avobenzone 3%, Homosalate 12%, Octisalate 5%, Octycrylene 1.7%, Oxybenzone 3%" ] }, { "effective_time": "20120323", "inactive_ingredient": [ "WATER, DIPROPYLENE GLYCOL, GLYCERIN, BETAINE, ALCOHOL, PANTHENOL, DIMETHICONE, TREHALOSE, HYALURONATE SODIUM, TROLAMINE, METHYLPARABEN, DIACETYL BENZOYL LATHYROL, NIACINAMIDE, ETHYLPARABEN, PROPYLPARABEN" ], "keep_out_of_reach_of_children": [ "Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center right away." ], "purpose": [ "To whiten skin." ], "warnings": [ "For external use only." ], "when_using": [ "When Using Keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "O HUI white-skin science white calming mask DIACETYL BENZOYL LATHYROL, MACELIGNAN DIACETYL BENZOYL LATHYROL DIACETYL BENZOYL LATHYROL MACELIGNAN MACELIGNAN WATER DIPROPYLENE GLYCOL GLYCERIN BETAINE ALCOHOL PANTHENOL DIMETHICONE TREHALOSE HYALURONATE SODIUM TROLAMINE METHYLPARABEN DIACETYL BENZOYL LATHYROL NIACINAMIDE ETHYLPARABEN PROPYLPARABEN" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Apply evenly to skin." ], "stop_use": [ "Stop Use Stop use if a rash or irritation develops and lasts." ], "package_label_principal_display_panel": [ "Calming Whitening Mask OH Calming Whitening Mask" ], "indications_and_usage": [ "Helps you back to the light at birth." ], "set_id": "06f3b91e-9caf-4a95-82d0-739615cf4f0f", "id": "6f8c605a-b8f9-4fd7-b306-614200d1658b", "active_ingredient": [ "Active Ingredients DIACETYL BENZOYL LATHYROL 0.11g/100g MACELIGNAN 0.01g/100g" ] }, { "effective_time": "20120827", "inactive_ingredient": [ "INACTIVE INGREDIENT Inactive Ingredients: WATER, CYCLOPENTASILOXANE, TALC, DIPROPYLENE GLYCOL, GLYCERIN, PEG-10 DIMETHICONE, CYCLOMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE, NIACINAMIDE, PHENYL TRIMETHICONE, IRON OXIDES, BETAINE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, HEXYL LAURATE, NELUMBO NUCIFERA FLOWER WATER, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, C12-14 PARETH-3, ACRYLATES/DIMETHICONE COPOLYMER, PHENOXYETHANOL, METHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, PALMITIC ACID, FRAGRANCE, METHYLPARABEN, PROPYLPARABEN, TOCOPHERYL ACETATE, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, DIOSPYROS KAKI LEAF EXTRACT, HYDROGENATED LECITHIN, RUBUS FRUTICOSUS (BLACKBERRY) FRUIT EXTRACT, SEA WATER, ACACIA SENEGAL FLOWER/STEM EXTRACT, ARNICA MONTANA FLOWER EXTRACT, CENTAUREA CYANUS FLOWER EXTRACT, DIANTHUS CARYOPHYLLUS FLOWER EXTRACT, FREESIA REFRACTA EXTRACT, IRIS VERSICOLOR EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER/LEAF EXTRACT, ZANTEDESCHIA AETHIOPICA FLOWER/STEM EXTRACT, HYDROGENATED VEGETABLE OIL, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, NEOFINETIA FALCATA CALLUS CULTURE EXTRACT, BUTYLPARABEN, ADENOSINE, SODIUM HYALURONATE, XANTHAN GUM, PEARL POWDER, ALUMINUM SILICATE, LECITHIN" ], "purpose": [ "PURPOSE Purpose: This smooth foundation makes your skin feel soft as velvet texture." ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN" ], "warnings": [ "WARNINGS Cautions: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rash appear. Keep out of reach of children. Replace the cap after use." ], "spl_product_data_elements": [ "ORCHID SECRET FOUNDATION 21 SPF28 PA PLUS PLUS TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE WATER CYCLOMETHICONE 5 TALC DIPROPYLENE GLYCOL GLYCERIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION How to Use: Apply an appropriate amount to the skin evenly." ], "package_label_principal_display_panel": [ "PACKAGE LABEL. PRINCIPAL DISPLAY PANEL Image of carton" ], "indications_and_usage": [ "INDICATIONS AND USAGE How to Use: Apply an appropriate amount to the skin evenly." ], "set_id": "07469133-4a35-4ff8-89a1-50b2257db118", "id": "c4c0c73a-1ca9-4ae1-a0c6-36eac080c56f", "active_ingredient": [ "ACTIVE INGREDIENT Active Ingredients: TITANIUM DIOXIDE 7.9%, ETHYLHEXYL METHOXYCINNAMATE 3%, ZINC OXIDE 1.9%" ] }, { "effective_time": "20100324", "inactive_ingredient": [ "Inactive ingredients Aqua (Water), Cyclopentasiloxane, Butylene glycol, Cyclohexasiloxane, Ethylhexyl stearate, Dimethicone, Phenyl trimethicone, Disteardimonium hectorite, Dimethicone copolyol, Magnesium sulfate, Phenoxyethanol, Cetyl PEG/PPG-10/1 Dimethicone, Tocopheryl acetate, Hexyl laurate, Polyglyceryl-4 isostearate, Propylene carbonate, Glycerin, Panthenol, Propylene glycol, Aluminum stearate, Alumina, Triethoxycaprylylsilane, Methylparaben, Panax ginseng root extract, Isopropyl palmitate, Butylparaben, Ethylparaben, Foeniculum vulgare (Fennel) fruit extract, Lecithin, Tetrasodium EDTA, Isobutylparaben, Propylparaben, BHT, [+/- (may contain) Mica, CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides)." ], "purpose": [ "Uses Provides minimal protection against adverse effects of the sun Higher SPF gives more protection" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed get medical help." ], "questions": [ "Questions? 1-866-75-BOOTS" ], "spl_product_data_elements": [ "No7 Radiant Glow Foundation Sunscreen SPF 15 Cream 05 Octinoxate and Titanium Dioxide OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER CYCLOMETHICONE 5 BUTYLENE GLYCOL CYCLOMETHICONE 6 DIMETHICONE PHENYL TRIMETHICONE MAGNESIUM SULFATE PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE, DL- HEXYL LAURATE POLYGLYCERYL-4 ISOSTEARATE PROPYLENE CARBONATE GLYCERIN PANTHENOL PROPYLENE GLYCOL ALUMINUM STEARATE ALUMINUM OXIDE OCTYLTRIETHOXYSILANE METHYLPARABEN ASIAN GINSENG ISOPROPYL PALMITATE BUTYLPARABEN ETHYLPARABEN FENNEL OIL LECITHIN, SOYBEAN EDETATE SODIUM ISOBUTYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE" ], "description": [ "Perfect lighting... Look beautifully radiant in any light with this light reflecting, moisturising foundation. Provides a natural, luminous finish, while soft, lightweight colour helps keep skin looking naturally flawless all day long. Fragrance free and easy to blend without blocking your pores. Ready to face the day... Shake before use. Dot onto your face and blend smoothly and evenly with your fingers or a sponge, working downwards and outwards from the centre of your face. Non-pore blocking.", "Look beautifully radiant in any light with this light reflecting, moisturising foundation. Provides a natural, luminous finish, while soft, lightweight colour helps keep skin looking naturally flawless all day long. Shake well before use. Blend on smoothly and evenly with your fingers or a sponge. Non-pore blocking." ], "warnings_and_cautions": [ "Warnings For external use only When using this product Keep out of eyes. Rinse with water to remove." ], "ask_doctor": [ "Stop use and ask a doctor if rash or irritation develops and lasts" ], "openfda": {}, "version": "1", "storage_and_handling": [ "Other information Do not store above 30 o C or 86 o F" ], "information_for_patients": [ "www.boots.com Mfd in France for BBI NG2 3AA. UK Dist in the USA by Boots Retail USA Inc Stamford CT 06901", "www.boots.com Mfd in France for BBI Ltd NG2 3AA. UK Dist in the USA by Boots Retail USA Inc. Stamford CT 06901 USA: Questions? 1-866-75-BOOTS" ], "package_label_principal_display_panel": [ "No7 Radiant Glow Lustre Rayonnant Foundation Fond de Teint For a natural luminous finish Sunscreen SPF 15 Hypo-allergenic Boots 30ml e 1 US Fl. Oz Radiant Glow Fdn carton.jpg Radiant Glow Fdn carton", "Bottle label Radiant Glow Foundation Sunscreen SPF 15 Hypo-allergenic Boots 30ml e 1 US Fl. Oz Radiant Glow Fdn bottle labels.jpg Radiant Glow Fdn bottle labels" ], "indications_and_usage": [ "Directions Use as a normal foundation Apply evenly at least 15 minutes before sun exposure Reapply as needed Not intended for children under the age of 12 Not intended for protection while sunbathing" ], "set_id": "075b2b89-1f28-4446-be6e-962927df1c3d", "id": "4d7e37f1-cc33-4ab2-8ff0-e9641d00d362", "active_ingredient": [ "Active Ingredients Purpose Octinoxate 5% Sunscreens Titanium Dioxide 1.6%", "Bottle label Active Ingredients: Octinoxate 5% Titanium Dioxide 1.6%" ] }, { "effective_time": "20130416", "inactive_ingredient": [ "Inactive ingredients alcohol, aloe barbadensis leaf juice, arginine, butylparaben, cetearyl isononanoate, dipropylene glycol dicaprylate/dicaprate, ethylparaben, eucalyptus globulus leaf oil, hexyl decyl laurate, hexyldecanole, melaleuca alternifolia (tea tree) leaf oil, menthol, methylparaben, ozokerite, phenoxyethanol, poloxamer 407, propylparaben, thymol, tocopheryl nicotinate (vitamin e), zinc chloride" ], "purpose": [ "Purpose Cold sore/fever blister treatment/first aid antiseptic" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222." ], "warnings": [ "Warnings For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician. Allergy Alert: Do not use if you are allergic to any of the ingredients in this product. When using this product avoid contact with eyes. Use only as directed. Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.." ], "questions": [ "Questions or Comments? Call us toll-free at 1-877-242-3234 Monday-Friday, 9 a.m. to 5 p.m. EST . Serious side effects associated with use of this product may be reported to this number." ], "spl_product_data_elements": [ "ShopKo Cold Sore Treatment Camphor Benzalkonium Chloride Benzalkonium CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) Alcohol Aloe Vera Leaf Arginine Butylparaben Ceresin Cetearyl Isononanoate Corymbia Citriodora Leaf Oil Dipropylene Glycol Caprate/Caprylate Diester Ethylparaben Hexyldecanol Hexyldecyl Laurate Levomenthol Methylparaben PHENOXYETHANOL Poloxamer 407 Propylparaben Tea Tree Oil Thymol TOCOPHERYL NICOTINATE, D-.ALPHA. Zinc Chloride" ], "openfda": {}, "version": "2", "dosage_and_administration": [ "Directions • clean the affected area • apply a small amount of this product to the affected area 1 to 3 times daily • rub in gently • may be covered with a sterile bandage • wash hands before and after applying cream • do not share this product with anyone • children under 12 years of age : ask a doctor" ], "storage_and_handling": [ "Other information store at room temperature" ], "package_label_principal_display_panel": [ "Shopko Cold Sore Treatment" ], "indications_and_usage": [ "Uses • for treatment of cold sores/fever blisters on the face or lips • temporarily relieves the symptoms of itching and pain associated with cold sores/fever blisters • first aid to help protect against infection in minor cuts, scrapes, burns, and sores" ], "set_id": "07807733-2bcf-4384-8551-7e27acb68a5f", "id": "18f673d3-d34e-46ec-adcd-dfe7f0e1ca6f", "active_ingredient": [ "Active ingredients Benzalkonium chloride 0.13% Camphor 3.0%" ] }, { "effective_time": "20110506", "inactive_ingredient": [ "INACTIVE INGREDIENT Other Ingredients: Water/Aqua/Eau, Isostearyl Palmitate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Oleic Acid, Glycerin, C12-20 Acid PEG-8 Ester, Polysorbate 40, Triethanolamine, Magnesium Aluminum Silicate, Dimethicone Copolyol, Phenyl Trimethicone, Sodium Hyaluronate, Retinyl Linoleate, Tocopherol, Glyceryl Stearate SE, Sucrose Laurate, Trehalose, Lecithin, Phospholipids, Tridecyl Salicylate, Decyl Glucoside, PEG-40 Stearate, Sorbitan Palmitate, Sorbitan Stearate, Behenyl Alcohol, Carbomer, Xanthan Gum, Disodium EDTA, Kaolin, Silica, Cyclopentasiloxane, Dimethiconol, Parfum/Fragrance, Butylphenyl Methylpropional, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)." ], "keep_out_of_reach_of_children": [ "OTC - KEEP OUT OF REACH OF CHILDREN Keep out of reach of children." ], "purpose": [ "OTC - PURPOSE SPF 8 provides sun protection." ], "warnings": [ "WARNINGS Warning: For external use only. Keep out of eyes.Stop use and see a doctor is rash or irritation develops and lasts. Keep out of reach of children." ], "when_using": [ "OTC - WHEN USING Keep out of eyes." ], "spl_product_data_elements": [ "Flawless Finish Bare Perfection Makeup SPF 8 Honey Beige Octinoxate OCTINOXATE OCTINOXATE WATER TITANIUM DIOXIDE BUTYLENE GLYCOL ALKYL (C12-15) BENZOATE DIMETHICONE OLEIC ACID GLYCERIN POLYSORBATE 40 MAGNESIUM ALUMINUM SILICATE TROLAMINE PHENYL TRIMETHICONE KAOLIN XANTHAN GUM PHENOXYETHANOL SUCROSE LAURATE DICAPRYLYL CARBONATE GLYCERYL MONOSTEARATE METHYLPARABEN DOCOSANOL PROPYLPARABEN SORBITAN MONOPALMITATE Honey Beige" ], "description": [ "DESCRIPTION For normal skin. Medium coverage. Natural finish. This oil free liquid makeup gives skin a firmer look and reflects light to soften fine lines. SPF 8 provides sun protection. Clinically, dermatologist and allergy tested." ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DOSAGE & ADMINISTRATION Smooth on to face." ], "package_label_principal_display_panel": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Flawless Finish Bare Perfection Makeup Carton" ], "indications_and_usage": [ "INDICATIONS AND USAGE To Use: Smooth on to face before sun exposure." ], "set_id": "079abd47-697d-45ce-910c-9a1658742d69", "id": "271a0451-07d4-4e0d-8a24-439dda4eb863", "active_ingredient": [ "OTC - ACTIVE INGREDIENT Active Ingredient: Octinoxate 4.0% w/w." ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CYCLOPENTASILOXANE•MICA• TRIETHOXYCAPRYLYLSILANE•DIPROPYLENE GLYCOL•PROPYLENE GLYCOL•PHENYL TRIMETHICONE•DIMETHICONE CROSSPOLYMER• LAURYL PEG-8 DIMETHICONE•SILICA•METHICONE• DIMETHICONE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•DISTEARDIMONIUM HECTORITE• POLYGLYCERYL-6 POLYRICINOLEATE•MANNAN• SODIUM CHLORIDE•LECITHIN•PROPYLENE CARBONATE•CITRUS PARADISI(GRAPEFRUIT) FRUIT EXTRACT•METHYLPARABEN•DISODIUM EDTA•AMETHYST POWDER•RUBY POWDER• QUARTZ•NEPHRITE POWDER•SAPPHIRE POWDER• TOURMALINE•BUTYLENE GLYCOL•CENTELLA ASIATICA EXTRACT•CAMELLIA SINENSIS LEAF EXTRACT•HEDERA HELIX (IVY) LEAF/STEM EXTRACT•ANTHEMIS NOBILIS FLOWER EXTRACT• FRAGRANCE•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging." ], "when_using": [ "Uses Helps prevent sunburn", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT 32800285 octinoxate, titanium oxide and zinc oxide cream OCTINOXATE OCTINOXATE WATER TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "SHIMMERING BB CREAM SUNSCREEN CREAM SPF20 This BB cream contains \"Crystal Modeling Powder\" which offers a radian, luminous complexion and \"Jewel Repair Complex\" which is a skin repair complex that keeps skin healthy. Image-label-32800285-rev" ], "set_id": "07d4e9a6-8731-5c4f-e054-00144ff88e88", "id": "07d4e9a6-8732-5c4f-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients OCTINOXATE.......... .5.5% TITANIUM DIOXIDE .5.7% ZINC OXIDE ............. 3.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients CYCLOPENTASILOXANE•PHENYL TRIMETHICONE• CYCLOHEXASILOXANE•BUTYLENE GLYCOL• ISODODECANE•CETYLEG/PPG-10/1 DIMETHICONE• NIACINAMIDE•METHYLPROPANEDIOL•BUTYLENE GLYCOL•DICAPRYLATE/DICAPRATE•POLYGLYCERYL-4 ISOSTEARATE•SODIUM CHLORIDE•METHYL METHACRYLATE CROSSPOLYMER•HYDROGENATED POLYISOBUTENE•DISTEARDIMONIUM HECTORITE• SORBITAN ISOSTEARATE•OZOKERITE•DIMETHICONE• HEXYL LAURATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•HYDROGENATED POLY(C6-14 OLEFIN)• CAPRYLIC/CAPRIC GLYCERIDES•ETHYLHEXYLGLYCERIN• ALUMINUM HYDROXIDE•BEESWAX•STEARIC ACID• FRAGRANCE(PARFUM)•TRIETHOXYCAPRYLYLSILANE• PROPYLENE CARBONATE•DISODIUM EDTA•PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL•RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS•ADENOSINE•PORTULACA OLERACEA EXTRACT• XANTHAN GUM•SODIUM HYALURONATE•PLUKENETIA VOLUBILIS SEED OIL•ALUMINA•RETINOL•LINOLEIC ACID• CERAMIDE 3•TOCOPHEROL•ASCORBIC ACID•HYDROLYZED EXTENSIN•GLYCERIN•SCHINUS TEREBINTHIFOLIUS SEED EXTRACT•PHENOXYETHANOL•GYNOSTEMMA PENTAPHYLLUM LEAF/STEM EXTRACT•CALCIUM ALUMINUM BOROSILICATE•BETA-GLUCAN• METHYLPARABEN•BUTYLPARABEN•ETHYLPARABEN• ISOBUTYLPARABEN•PROPYLPARABEN• IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. After basic skincare, dispense an adequate amount and apply evenly to the skin. Then, pat lightly with the palms for full absorption." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT POWER PERFECTION 32800311 octinoxate, titanium dioxide and zinc oxide OCTINOXATE OCTINOXATE ALUMINUM OXIDE ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "FACE IT POWER PERFECTION BB CREAM 01 LIGHT BEIGE Label" ], "set_id": "07d5e76a-da75-04b4-e054-00144ff88e88", "id": "07d5e76a-da76-04b4-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients OCTINOXATE • • • • • • • • • • • 5.0% TITANIUM DIOXIDE • • • • • • • • 10.0% ZINC OXIDE • • • • • • • • • • • 2.9%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients CYCLOPENTASILOXANE•WATER•BUTYLENE GLYCOL• DIMETHICONE•SD ALCOHOL 40-B•HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER•CAPRYLIC/CAPRIC GLYCERIDES•ISOHEXADECANE•SODIUM CHLORIDE• ALUMINUM HYDROXIDE•METHYL METHACRYLATE CROSSPOLYMER•STEARIC ACID•PEG-10 DIMETHICONE• 1,2-HEXANEDIOL•TRIETHOXYCAPRYLYLSILANE•SILICA• DISODIUM EDTA•ALOE BARBADENSIS LEAF EXTRACT• PORTULACA OLERACEA EXTRACT•ADANSONIA DIGITATA SEED EXTRACT•ALCOHOL•PHENOXYETHANOL• METHYLPARABEN•PROPYLPARABEN•ETHYLPARABEN• BUTYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE• IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Shake lightly 3 – 5 times before use. Dispense an adequate amount and apply evenly to the skin. Then, pat lightly with fingers for full absorption. Re-apply a small amount to parts that require extra coverage and pat with fingers. Double cleansing is recommended as this product adheres tightly to the skin. FACE IT One-ste p BB Cleanser may be used for simple and easy cleansing." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE it 32800378 octinoxate, titanium oxide and zind oxide cream Octinoxate Octinoxate Titanium Dioxide Titanium Dioxide WATER Zinc Oxide Zinc Oxide" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "BB SUNSCREEN CREAM SPF50+ 01 LIGHT BEIGE Image-label-32800378-rev" ], "set_id": "07d78c56-a6cf-4d69-e054-00144ff8d46c", "id": "07d78c56-a6d0-4d69-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE • • • • • • • 7.3% TITANIUM DIOXIDE • • • 15.0% ZINC OXIDE • • • • • • • • 5.9%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CYCLOPENTASILOXANE•PHENYL TRIMETHICONE• CYCLOHEXASILOXANE•BUTYLENE GLYCOL•ISODODECANE• CETYL PEG/PPG-10/1 DIMETHICONE•NIACINAMIDE• METHYLPROPANEDIOL•BUTYLENE GLYCOL DICAPRYLATE/ DICAPRATE•POLYGLYCERYL-4 ISOSTEARATE•SODIUM CHLORIDE•HYDROGENATED POLYISOBUTENE• DISTEARDIMONIUM HECTORITE•METHYL METHACRYLATE• CROSSPOLYMER•SORBITAN ISOSTEARATE•OZOKERITE• DIMETHICONE•HEXYL LAURATE•DIMETHICONE/VINYL• DIMETHICONE CROSSPOLYMER•HYDROGENATED POLY (C6-14 OLEFIN)•CAPRYLIC/CAPRIC GLYCERIDES• ETHYLHEXYLGLYCERIN•ALUMINUM HYDROXIDE•BEESWAX• STEARIC ACID•TRIETHOXYCAPRYLYLSILANE•FRAGRANCE (PARFUM)•PROPYLENE CARBONATE•DISODIUM EDTA• PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL• RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS•ADENOSINE•PORTULACA OLERACEA EXTRACT•XANTHAN GUM•SODIUM HYALURONATE•PLUKENETIA VOLUBILIS SEED OIL• ALUMINA•RETINOL•LINOLEIC ACID•CERAMIDE 3• TOCOPHEROL•ASCORBIC ACID•HYDROLYZED EXTENSIN• GLYCERIN•SCHINUS TEREBINTHIFOLIUS SEED EXTRACT• PHENOXYETHANOL•GYNOSTEMMA PENTAPHYLLUM LEAF/STEM•EXTRACT•CALCIUM ALUMINUM BOROSILICATE• BETA-GLUCAN•METHYLPARABEN•BUTYLPARABEN• ETHYLPARABEN•ISOBUTYLPARABEN• PROPYLPARABEN•IRON OXIDES (CI 77491, CI 77492, CI 77499)•ZINC OXIDE (CI 77947)" ], "purpose": [ "Purpose Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert : Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. After basic skincare, dispense an adequate amount and apply evenly to the skin. Then, pat lightly with the palms for full absorption." ], "questions": [ "Questions Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT POWER PERFECTION 32800312 octinoxate and titanium dioxide cream OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "POWER PERFECTION BB CREAM SUNSCREEN CREAM SPF37 02 NATURAL BEIGE A BB cream providing total skin treatment to achieve a \"POWER PERFECTION SKIN\" by imparting proactive care to overall skin problems, including bagginess, roughness and dryness. Image-label-32800312-rev" ], "set_id": "07d7d0ff-6505-147c-e054-00144ff8d46c", "id": "07d7d0ff-6506-147c-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE • • • • • • • • • • • • 5.0% TITANIUM DIOXIDE • • • • • • • • 10.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients CYCLOPENTASILOXANE•WATER•BUTYLENE GLYCOL• DIMETHICONE•SD ALCOHOL 40-B•HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER•CAPRYLIC/CAPRIC GLYCERIDES•ISOHEXADECANE•SODIUM CHLORIDE• ALUMINUM HYDROXIDE•METHYL METHACRYLATE CROSSPOLYMER•STEARIC ACID•PEG-10 DIMETHICONE• 1,2-HEXANEDIOL•PEG-10 DIMETHICONE•SILICA• DISODIUM EDTA•TRIETHOXYCAPRYLYLSILANE•ALOE BARBADENSIS LEAF EXTRACT• TRIETHOXYCAPRYLYLSILANE•PORTULACA OLERACEA EXTRACT•BUTYLENE GLYCOL•ADANSONIA DIGITATA SEED EXTRACT• ALCOHOL•PHENOXYETHANOL•METHYLPARABEN• PROPYLPARABEN•ETHYLPARABEN•BUTYLPARABEN• ISOBUTYLPARABEN•PHENOXYETHANOL• FRAGRANCE•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Pupose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Shake lightly 3 – 5 times before use. Dispe nse an adequate amount and apply evenly to the skin. Then, pat lightly with fingers for full absorption. Re-apply a small amount to parts that require extra coverage and pat with fingers. Double cleansing is recommended as this product adheres tightly to the skin. FACE IT One-step BB Cleanser may be used for simple and easy cleansing." ], "questions": [ "Questions Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT BB (Natural Beige) 32800379 octinoxate, titanium oxide and zinc oxide cream ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "FACE it BB SUNSCREEN CREAM SPF50+ 02 NATURAL BEIGE This liquid type BB cream replenishes moisture from within and provides perfect protection agains UV rays while sebum and sweat-resistant formula keeps skin moist all day long. Image-label-32800379-rev" ], "set_id": "07d7d0ff-6507-147c-e054-00144ff8d46c", "id": "07d7d0ff-6508-147c-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE • • • • • • • • • • 7.3% TITANIUM DIOXIDE • • • • •• 14.7% ZINC OXIDE • • • • • • • • • • • 5.9%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CYCLOPENTASILOXANE•PHENYL TRIMETHICONE• CYCLOHEXASILOXANE•BUTYLENE GLYCOL•ISODODECANE•CETYL PEG/PPG-10/1 DIMETHICONE•NIACINAMIDE•METHYLPROPANEDIOL• BUTYLENE GLYCOL•DICAPRYLATE/DICAPRATE•POLYGLYCERYL-4 ISOSTEARATE•SODIUM CHLORIDE•HYDROGENATED POLYISOBUTENE•DISTEARDIMONIUM HECTORITE•METHYL METHACRYLATE CROSSPOLYMER•SORBITAN ISOSTEARATE• OZOKERITE•DIMETHICONE•HEXYL LAURATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•HYDROGENATED POLY (C6-14 OLEFIN)•CAPRYLIC/CAPRIC GLYCERIDES• ETHYLHEXYLGLYCERIN•ALUMINUM HYDROXIDE•BEESWAX• STEARIC ACID•TRIETHOXYCAPRYLYLSILANE•FRAGRANCE(PARFUM)• PROPYLENE CARBONATE•DISODIUM EDTA•PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL•RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS•ADENOSINE•PORTULACA OLERACEA EXTRACT•XANTHAN GUM•SODIUM HYALURONATE• PLUKENETIA VOLUBILIS SEED OIL•ALUMINA•RETINOL•LINOLEIC ACID•CERAMIDE 3•TOCOPHEROL•ASCORBIC ACID•HYDROLYZED EXTENSIN•GLYCERIN•SCHINUS TEREBINTHIFOLIUS SEED EXTRACT• PHENOXYETHANOL•GYNOSTEMMA PENTAPHYLLUM LEAF/STEM EXTRACT•CALCIUM ALUMINUM BOROSILICATE•BETA-GLUCAN• METHYLPARABEN•BUTYLPARABEN•ETHYLPARABEN• ISOBUTYLPARABEN•PROPYLPARABEN•IRON OXIDES (CI 77491, CI 77492, CI 77499)•ZINC OXIDE (CI 77947)" ], "purpose": [ "Purpose Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. After basic skincare, dispense an adequate amount and apply evenly to the skin. Then, pat lightly with the palms for full absorption." ], "questions": [ "Questions Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT POWER PERFECTION 32800408 octinoxate and titanium dioxide cream OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "POWER PERFECTION BB CREAM SUNSCREEN CREAM SPF 37 02 NATURAL BEIGE A BB cream providing total skin treatment to achieve a \"power perfection skin\" by imparting proactive care to overall skin problems, including bagginess, roughness and dryness. Image-label-32800408-rev" ], "set_id": "07d899a0-08ec-57b3-e054-00144ff88e88", "id": "07d899a0-08ed-57b3-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients OCTINOXATE • • • • • • • • • 5.0% TITANIUM DIOXIDE • • • 9.7%" ] }, { "effective_time": "20130917", "inactive_ingredient": [ "Inactive Ingredients Water, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, VP/Hexadecene Copolymer, Behenyl Alcohol, Silica, Sodium Polyacrylate, Trideceth-6, Dimethicone, Trimethylsiloxysilicate, Caprylyl Methicone, Ethylhexyl Stearate, PEG-4 Dilaurate, PEG-4 Laurate, Xanthan Gum, BHT, Disodium EDTA, PEG-4, Ethylhexylglycerin, Methylparaben, Propylparaben, Ethylparaben, Iodopropynyl Butylcarbamate, Fragrance." ], "purpose": [ "Purpose Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "questions": [ "Questions or comments? 1-800-632-6900" ], "spl_product_data_elements": [ "Kroger Sheer Dry Touch Sunscreen SPF 55 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER DIMETHICONE OXYBENZONE OXYBENZONE BUTYLOCTYL SALICYLATE PEG-100 STEARATE GLYCERYL MONOSTEARATE PHENOXYETHANOL TRIDECETH-6 METHYLPARABEN PROPYLPARABEN DOCOSANOL EDETATE DISODIUM SILICON DIOXIDE PEG-4 LAURATE ETHYLHEXYL STEARATE CAPRYLYL TRISILOXANE ETHYLPARABEN BUTYLATED HYDROXYTOLUENE XANTHAN GUM IODOPROPYNYL BUTYLCARBAMATE" ], "openfda": {}, "version": "4", "dosage_and_administration": [ "Directions apply liberally 15 minutes before sun exposure reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses children under 6 months of age: Ask a doctor" ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "spl_unclassified_section": [ "Other Information protect this product from excessive heat and direct sun" ], "package_label_principal_display_panel": [ "COMPARE TO NEUTROGENA ULTRA SHEER SHEER dry-touch sunscreen 55 Broad Spectrum SPF 55 Water Resistant (80 Minutes) Light Clean Feel Dermatologist Tested Oil Free Wont Clog Pores UVA/UVB Protection 4 FL OZ (118 mL) utythjrled.jpg" ], "indications_and_usage": [ "Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun" ], "set_id": "07ea7d91-ad23-436d-a985-fca207ae69ef", "id": "9a8743f0-ad25-4ff5-a470-d70255d8a07f", "active_ingredient": [ "Active ingredients Avobenzone 3.0 % Homosalate 10.0% Octisalate 5.0% Octocrylene 2.8% Oxybenzone 6.0%" ] }, { "effective_time": "20141115", "inactive_ingredient": [ "OTHER INGREDIENTS Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodiumm Salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben." ], "purpose": [ "PURPOSE Analgesic/Counterirritant External Analgesic" ], "keep_out_of_reach_of_children": [ "KEEP OUT OF REACH OF CHILDREN Keep out of reach of children" ], "warnings": [ "WARNINGS For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not cover with bandage. Do not use on wounds or damaged skin. Consult physician for children under 12. Do not use if you are allergic to Menthol Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days Or rash, itching or excessive skin irritation occurs." ], "spl_product_data_elements": [ "MENDEX MENTHOL, CAPSAICIN WATER GLYCERIN POLYSORBATE 80 ALOE VERA LEAF EDETATE DISODIUM DIAZOLIDINYL UREA METHYLPARABEN IODOPROPYNYL BUTYLCARBAMATE PROPYLPARABEN MENTHOL MENTHOL CAPSAICIN CAPSAICIN" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "DIRECTIONS Adults and children 12 years and over apply to affected area: change patch 1 to 2 times daily Children under 12 years, consult physician before use How to apply- Clean and dry affected area Cut open pouch and remove patch Remove protective film and apply directly to area of pain Apply to affected area not more than 3 times daily Wash hands with soap after applying patch Reseal pouch containing unused patches" ], "package_label_principal_display_panel": [ "MENDEX 25 Patches (69329-013-25) mendex label small.jpg" ], "indications_and_usage": [ "USES Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness." ], "set_id": "07eec701-f579-7394-e054-00144ff88e88", "id": "07eec701-f57a-7394-e054-00144ff88e88", "active_ingredient": [ "ACTIVE INGREDIENTS Menthol 5.00% Capsaicin 0.0375%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•TITANIUM DIOXIDE•CYCLOMENTHICONE• BUTYLENE GLYCOL•HEXYL LAURATE•GLYCERIN• SD ALCOHOL 40-B•BIOSACCHARIDE GUM-1• PORTULACA OLERACEA EXTRACT• HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER• C9-15 FLUOROALCOHOL PHOSPHATE•SQUALANE• PHENOXYETHANOL•TALC•METHYLPARABEN• ALUMINUM HYDROXIDE•ETHYLPARABEN• POLYSORBATE 60•BUTYLPFENYL METHYLPROPIONAL•HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE•LINALOOL• BUTYLPFENYL METHYLPROPIONAL•CITRONELLOL• LIMONENE•SEA WATER•PONCIRUS TRIFOLIATA FRUIT EXTRACT•TRIETHOXYCAPRYLYLSILANE• FRAGRANCE•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Apply after skincare products. Blend evenly with fingertips and gently pat into skin." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AQUA TINTED 32800420 octinoxate WATER OCTINOXATE OCTINOXATE" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "AQUA TINTED BB SUNSCREEN CREAM SPF20 01 LIGHT BEIGE With a 70% MOISTURE CONTENT, including DEEP SEA WATER, a light application provides a sense of coolness and freshness the moment it touches the skin. FACE it Image-label-32800420-rev" ], "set_id": "080ff250-52b3-0992-e054-00144ff88e88", "id": "080ff250-52b4-0992-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients OCTINOXATE...5.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•DIPHENYLSILOXY PHENYL TRIMETHICONE•CYCLOPENTASILOXANE•GLYCERIN•CYCLOHEXASILOXANE• BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE•MALTITOL• SORBITAN ISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE•TRIMETHYLSILOXYSILICATE•TRIBEHENIN• PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE•DISTEARDIMONIUM HECTORITE•MAGNESIUM SULFATE• DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•METHYL METHACRYLATE CROSSPOLYMER•DIPHENYL DIMETHICONE•VP/HEXADECENE COPOLYMER•PHENOXYETHANOL•TRIETHOXYCAPRYLYLSILANE•CERESIN• ALUMINUM HYDROXIDE•STEARIC ACID•ETHYLHEXYLGLYCERIN•ADENOSINE•DIMETHICONE• DISODIUM EDTA•SODIUM PCA•SODIUM HYALURONATE•UREA•TREHALOSE•POLYQUATERNIUM-51•CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•ACHYRANTHES FAURIEI ROOT EXTRACT•ACTINIDIA POLYGAMA FRUIT EXTRACT• IMPERATA CYLINDRICA ROOT EXTRACT•POLYPERFLUOROMETHYLISOPROPYL ETHER• OXYGEN•PEG-8•CARBOMER•METHYLPARABEN•POTASSIUM SORBATE•BUTYLPARABEN• ETHYLPARABEN•PROPYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE(PARFUM)•IRON OXIDES (CI 77491, CI 77492, CI 77499)•MICA (CI 77019)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating" ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AURA COLOR CONTROL SPF30 (REFILL), 01 RADIANT BEIGE 32800659 octinoxate, titanium dioxide and zinc oxide cream WATER ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "FACE IT AURA COLOR CONTROL CREAM SPF30 (REFILL) 01 RADIANT BEIGE Label" ], "set_id": "080ff250-52b5-0992-e054-00144ff88e88", "id": "080ff250-52b6-0992-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients OCTINOXATE • • • • • • • 4.0% TITANIUM DIOXIDE • • • 11.5% ZINC OXIDE • • • • • • • • • 1.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•DIPHENYLSILOXY PHENYL TRIMETHICONE•CYCLOPENTASILOXANE•GLYCERIN•CYCLOHEXASILOXANE• BUTYLENE GLYCOL•BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE• MALTITOL•SORBITAN ISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE•TRIMETHYLSILOXYSILICATE• TRIBEHENIN•PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE•DISTEARDIMONIUM HECTORITE•MAGNESIUM SULFATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•METHYL METHACRYLATE CROSSPOLYMER•DIPHENYL DIMETHICONE•VP/HEXADECENE COPOLYMER•PHENOXYETHANOL•TRIETHOXYCAPRYLYLSILANE•CERESIN• ALUMINUM HYDROXIDE•STEARIC ACID•ETHYLHEXYLGLYCERIN•ADENOSINE•DIMETHICONE• DISODIUM EDTA•SODIUM PCA•SODIUM HYALURONATE•UREA•TREHALOSE•POLYQUATERNIUM-51•CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•ACHYRANTHES FAURIEI ROOT EXTRACT•ACTINIDIA POLYGAMA FRUIT EXTRACT• IMPERATA CYLINDRICA ROOT EXTRACT•POLYPERFLUOROMETHYLISOPROPYL ETHER•OXYGEN• PEG-8•CARBOMER•METHYLPARABEN•POTASSIUM SORBATE•BUTYLPARABEN•ETHYLPARABEN• PROPYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE (PARFUM)•IRON OXIDES (CI 77491, CI 77492, CI 77499)•MICA (CI 77019)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen", "Uses Helps prevent sunburn" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating." ], "questions": [ "Questions Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AURA COLOR CONTROL 32800660 octinoxate, titanium dioxide and zinc oxide WATER ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC CREAM AURA COLOR CONTROL SUNSCREEN CREAM (REFILL) SPF30 02 NATURAL BEIGE FACE IT CC CREAM is a color-controlling cream that brightens your complexion and keeps your morning makeup intact without any darkening. FACE it Image-label-32800660-rev" ], "set_id": "080ff250-52b7-0992-e054-00144ff88e88", "id": "080ff250-52b8-0992-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients OCTINOXATE............ 4.0% TITANIUM DIOXIDE 11.5% ZINC OXIDE............... 1.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•TITANIUM DIOXIDE•CYCLOMENTHICONE• BUTYLENE GLYCOL•HEXYL LAURATE•GLYCERIN• SD ALCOHOL 40-B•BIOSACCHARIDE GUM-1• PORTULACA OLERACEA EXTRACT• HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER• C9-15 FLUOROALCOHOL PHOSPHATE•SQUALANE• PHENOXYETHANOL•TALC•METHYLPARABEN• ALUMINUM HYDROXIDE, ETHYLPARABEN• POLYSORBATE 60•BUTYLPFENYL METHYLPROPIONAL•HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE•LINALOOL• BUTYLPFENYL METHYLPROPIONAL• CITRONELLOL•LIMONENE•SEA WATER• PONCIRUS TRIFOLIATA FRUIT EXTRACT• TRIETHOXYCAPRYLYLSILANE• FRAGRANCE•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Apply after skincare products. Blend evenly with fingertips and gently pat into skin." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AQUA TINTED 32800421 octinoxate OCTINOXATE OCTINOXATE WATER" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "AQUA TINTED BB SUNSCREEN CREAM SPF20 02 NATURAL BEIGE With a 70 % MOISTURE CONTENT, including DEEP SEA WATER, a light application provides a sense of coolness and freshness the moment it touches the skin. Image-label-32800421-rev" ], "set_id": "08105130-2d59-72c2-e054-00144ff8d46c", "id": "08105130-2d5a-72c2-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE • • • • • • • • • 5.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CYCLOPENTASILOXANE•CYCLOHEXASILOXANE• DIPROPYLENE GLYCOL•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•BETAINE• GLYCERIN•HYDROGENATED POLYISOBUTENE• DISTEARDIMONIUM HECTORITE•TALC•DIMETHICONE• MAGNESIUM SULFATE•PHENOXYETHANOL• METHYLPARABEN•DIMETHICONE/PEG-10/15 CROSSPOLYMER•POLYGLYCERYL-4 ISOSTEARATE•CETYL PEG/PPG-10/1 DIMETHICONE•BIS-VINYL DIMETHICONE/ DIMETHICONE COPOLYMER•STEARIC ACID• DISTEARYLDIMONIUM CHLORIDE• TRIETHOXYCAPRYLYLSILANE•ALUMINUM HYDROXIDE• PROPYLPARABEN•ETHYLPARABEN•TOCOPHERYL ACETATE• BUTYLPHENYL METHYLPROPIONAL•HYDROXYISOHEXYL 3- CYCLOHEXENE CARBOXALDEHYDE•HEXYL LAURATE• HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER• LINALOOL•PORTULACA OLERACEA EXTRACT•CITRONELLOL• LIMONENE•BUTYLENE GLYCOL•MEDICAGO SATIVA (ALFALFA) LEAF EXTRACT•RAPHANUS SATIVUS (RADISH) LEAF EXTRACT•TRIFOLIUM REPENS EXTRACT•BRASSICA OLERACEA ITALICA (BROCCOLI) SPROUT EXTRACT•SILICA• NELUMBO NUCIFERA LEAF EXTRACT•LYCIUM CHINENSE ROOT EXTRACT•KOCHIA SCOPARIA FRUIT EXTRACT• FRAGRANCE•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Apply after skincare products. Blend evenly with fingertips and gently pat into skin." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT HD PERFECT BB 32800472 octinoxate, titanium dioxide and zinc oxide TITANIUM DIOXIDE TITANIUM DIOXIDE WATER OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "HD PERFECT BB SUNSCREEN CREAM SPF35 01 LIGHT BEIGE Contains HD SKIN COMPLEX to meticulously conceal skin flaws and blemishes while covering widened pores and uneven skin surface to provide a fair and smooth HD skin acceptance. FACE it Image-label-32800472-rev" ], "set_id": "0810780e-0fad-04da-e054-00144ff8d46c", "id": "0810780e-0fae-04da-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE ...........6.0% TITANIUM DIOXIDE 7.0% ZINC OXIDE..............2.9%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CYCLOPENTASILOXANE•CYCLOHEXASILOXANE• DIPROPYLENE GLYCOL•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•BETAINE• GLYCERIN•HYDROGENATED POLYISOBUTENE• DISTEARDIMONIUM HECTORITE•DIMETHICONE•MAGNESIUM SULFATE•TALC•PHENOXYETHANOL•METHYLPARABEN• DIMETHICONE/PEG-10/15 CROSSPOLYMER•POLYGLYCERYL-4 ISOSTEARATE•CETYL PEG/PPG-10/1 DIMETHICONE• BIS-VINYL DIMETHICONE/DIMETHICONE COPOLYMER• STEARIC ACID•DISTEARYLDIMONIUM CHLORIDE• TRIETHOXYCAPRYLYLSILANE•ALUMINUM HYDROXIDE• PROPYLPARABEN•ETHYLPARABEN•TOCOPHERYL ACETATE• BUTYLPHENY METHYLPROPIONAL•HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE•HEXYL LAURATE• HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER• LINALOOL•PORTULACA OLERACEA EXTRACT•CITRONELLOL• LIMONENE•BUTYLENE GLYCOL•MEDICAGO SATIVA (ALFALFA) LEAF EXTRACT•RAPHANUS SATIVUS (RADISH) LEAF EXTRACT•TRIFOLIUM REPENS EXTRACT•BRASSICA OLERACEA ITALICA (BROCCOLI) SPROUT EXTRACT•SILICA• NELUMBO NUCIFERA LEAF EXTRACT•LYCIUM CHINENSE ROOT EXTRACT•KOCHIA SCOPARIA FRUIT EXTRACT•FRAGRANCE•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Apply after skincare products. Blend evenly with fingertips and gently pat into skin." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT HD PERFECT BB 32800473 octinoxate, zinc oxide and titanium dioxide TITANIUM DIOXIDE TITANIUM DIOXIDE WATER ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "HD PERFECT BB SUNSCREEN CREAM SPF35 01 NATURAL BEIGE Contains HD SKIN COMPLEX to meticulously conceal skin flaws and blemishes while covering widened pores and uneven skin surface to provide a fair and smooth HD skin acceptance. FACE it Image-label-32800473" ], "set_id": "0810780e-0fb1-04da-e054-00144ff8d46c", "id": "0810780e-0fb2-04da-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE ............6.0% TITANIUM DIOXIDE... 7.0% ZINC OXIDE................ 2.9%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•DIPHENYLSILOXY PHENYL TRIMETHICONE•CYCLOPENTASILOXANE•GLYCERIN•CYCLOHEXASILOXANE• BUTYLENE GLYCOL•BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE•MALTITOL•SORBITAN ISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE• TRIMETHYLSILOXYSILICATE•TRIBEHENIN•PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE• DISTEARDIMONIUM HECTORITE•MAGNESIUM SULFATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER• METHYL METHACRYLATE CROSSPOLYMER•DIPHENYL DIMETHICONE•VP/HEXADECENE COPOLYMER• PHENOXYETHANOL•MICA (CI 77019)•TRIETHOXYCAPRYLYLSILANE•CERESIN•ALUMINUM HYDROXIDE• STEARIC ACID•ETHYLHEXYLGLYCERIN•ADENOSINE•DIMETHICONE•DISODIUM EDTA•SODIUM PCA• SODIUM HYALURONATE•UREA•TREHALOSE•POLYQUATERNIUM-51•CITRUS RETICULATA (TANGERINE) PEEL EXTRACTVACHYRANTHES FAURIEI ROOT EXTRACT•ACTINIDIA POLYGAMA FRUIT EXTRACT• IMPERATA CYLINDRICA ROOT EXTRACT•POLYPERFLUOROMETHYLISOPROPYL ETHER• OXYGEN•PEG-8•CARBOMER•METHYLPARABEN•POTASSIUM SORBATE•BUTYLPARABEN• ETHYLPARABEN•PROPYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE(PARFUM)• IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Pump 1 – 2 times to release the formula. After skincare, apply evenly onto face in a light tapping motion using the enclosed CC puff. Do the same for the touch-ups." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AURA COLOR CONTROL 32800657 octinoxate, titanium dioxide and zinc oxide TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER OCTINOXATE OCTINOXATE" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC CREAM AURA COLOR CONTROL SUNSCREEN CREAM SPF30 01 RADIANT BEIGE FACE IT CC CREAM is a color-controlling cream that brightens your complexion and keeps your morning makeup intact without any darkening. FACE it Image-label-32800657-rev" ], "set_id": "0810780e-0fb5-04da-e054-00144ff8d46c", "id": "0810780e-0fb6-04da-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE............. 4.0% TITANIUM DIOXIDE 11.5% ZINC OXIDE................. 1.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•DIPHENYLSILOXY PHENYL TRIMETHICONE•CYCLOPENTASILOXANE•GLYCERIN•CYCLOHEXASILOXANE• BUTYLENE GLYCOL•BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE•CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•ACHYRANTHES FAURIEI ROOT EXTRACT• ACTINIDIA POLYGAMA FRUIT EXTRACT•IMPERATA CYLINDRICA ROOT EXTRACT•OXYGEN•MALTITOL• SORBITANISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE•TRIMETHYLSILOXYSILICATE• TRIBEHENIN•PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE•DISTEARDIMONIUM HECTORITE• MAGNESIUMSULFATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•DIPHENYL DIMETHICONE• VP/HEXADECENECOPOLYMER•METHYL METHACRYLATE CROSSPOLYMER•TRIETHOXYCAPRYLYLSILANE• CERESIN•ALUMINUMHYDROXIDE•STEARIC ACID•ETHYLHEXYLGLYCERIN•ADENOSINE•DIMETHICONE• SODIUM PCA•SODIUMHYALURONATE•UREA•TREHALOSE•POLYQUATERNIUM-51• POLYPERFLUOROMETHYLISOPROPYL ETHER•PEG-8•CARBOMER•DISODIUM EDTA• PHENOXYETHANOL•METHYLPARABEN•POTASSIUM SORBATE•BUTYLPARABEN• ETHYLPARABEN•PROPYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE(PARFUM)• MICA (CI 77019)•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Uses Helps prevent sunburn.", "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Pump 1 – 2 times to release the formula. After skincare, apply evenly onto face in a light tapping motion using the enclosed CC puff. Do the same for the touch-ups." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AURA COLOR CONTROL 32800658 octinoxate, titanium oxide and zinc oxide OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER" ], "other_safety_information": [ "Other information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC CREAM AURA COLOR CONTROL SUNSCREEN CREAM SPF30 02 NATURAL BEIGE FACE IT CC CREAM is a color-controlling cream that brightens your complexion and keeps your morning makeup intact without any darkening. FACE it Image-label-32800658-rev" ], "set_id": "08112381-fc1c-1cf1-e054-00144ff8d46c", "id": "08112381-fc1d-1cf1-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE............ 4.0% TITANIUM DIOXIDE 11.5% ZINC OXIDE................ 1.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CETYL ETHYLHEXANOATE•CYCLOPENTASILOXANE•BUTYLENE GLYCOL•METHYL TRIMETHICONE• NIACINAMIDE•DIPHENYLSILOXY PHENYL TRIMETHICONE•DIMETHICONE•SILICA•TROMETHAMINE• CYCLOHEXASILOXANE•PEG-10 DIMETHICONE•METHYL METHACRYLATE CROSSPOLYMER•POLYMETHYL METHACRYLATE•SORBITAN ISOSTEARATE•DIMETHICONE CROSSPOLYMER•DISTEARDIMONIUM HECTORITE• HEXYL LAURATE•DIMETHICONE/PEG-10/15 CROSSPOLYMER•CAPRYLIC/CAPRIC GLYCERIDES•MAGNESIUM SULFATE• ALUMINUM HYDROXIDE•STEARIC ACID•ETHYLHEXYL TRIAZONE•MICA•METHYLPARABEN•TRIETHOXYCAPRYLYLSILANE• DISTEARYLDIMONIUM CHLORIDE•PROPYLENE CARBONATE•POLYESTER-1•ETHYLPARABEN•SILICA DIMETHYL SILYLATE• DIMETHICONOL•ADENOSINE•DIPROPYLENE GLYCOL•SODIUM CITRATE•ALUMINA•TOCOPHEROL• CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT•CITRUS PARADISI• (GRAPEFRUIT) FRUIT EXTRACT•FRAGRANCE•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin. aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating. At the final stage of skincare, smooth out the CC cream onto entire face following the skin texture. Recommended to pump only once per application to release an adequate amount. Pump gently to avoid any spatter." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT SMART COLOR CONTROL 32800661 ensulizole, titanium dioxide and zinc oxide ZINC OXIDE ZINC OXIDE ENSULIZOLE ENSULIZOLE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun May stain or damage some fabrics or surfaces" ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC CREAM SMART CAPSULE CONTROL SUNSCREEN CREAM SPF40 PERFECT SKIN TONE FACE IT CC CREAM is a color-controlling cream that brightens your complexion and keeps your morning makeup intact without any darkening. FACE it Image-label-32800661-rev" ], "set_id": "0811c661-f0d1-312f-e054-00144ff8d46c", "id": "0811c661-f0d2-312f-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients ENSULIZOLE............. 2.8% TITANIUM DIOXIDE.. 8.1% ZINC OXIDE............. 10.6%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•DIPHENYLSILOXY PHENYL TRIMETHICONE•CYCLOPENTASILOXANE•GLYCERIN•CYCLOHEXASILOXANE• BUTYLENE GLYCOL•BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE• MALTITOL•SORBITAN ISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE•TRIMETHYLSILOXYSILICATE• TRIBEHENIN•PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE•DISTEARDIMONIUM HECTORITE• MAGNESIUM SULFATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•DIPHENYL DIMETHICONE• VP/HEXADECENE COPOLYMER•PHENOXYETHANOL•METHYL METHACRYLATE CROSSPOLYMER•MICA (CI 77019)• TRIETHOXYCAPRYLYLSILANE•CERESIN•ALUMINUM HYDROXIDE•SODIUM PCA•UREA•STEARIC ACID• ETHYLHEXYLGLYCERIN•ADENOSINE•TREHALOSE•POLYQUATERNIUM-51•DISODIUM EDTA•DIMETHICONE•SODIUM HYALURONATE•TRIACETIN•CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•ACHYRANTHES FAURIEI ROOT EXTRACT•ACTINIDIA POLYGAMA FRUIT EXTRACT•IMPERATA CYLINDRICA ROOT EXTRACT• POLYPERFLUOROMETHYLISOPROPYL ETHER•OXYGEN•PEG-8•CARBOMER•METHYLPARABEN• POTASSIUM SORBATE•BUTYLPARABEN•ETHYLPARABEN•PROPYLPARABEN• ISOBUTYLPARABEN•FRAGRANCE(PARFUM)•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin. aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating. 1. Pump 1 – 2 times to release the formula. 2. After skin care, apply evenly onto face in a light tapping motion using the enclosed CC puff. 3. Do the same for the touch-ups" ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AURA COLOR CONTROL 32800675 octinoxate, titanium oxide and zinc oxide TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE WATER" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun May stain or damage some fabrics or surfaces" ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC CREAM AURA COLOR CONTROL SUNSCREEN CREAM SPF30 03 MEDIUM BEIGE FACE IT CC CREAM is a color-controlling cream that brightens your complexion and keeps your morning makeup intact without any darkening. FACE it Image-label-32800675-rev" ], "set_id": "08121399-0955-4b48-e054-00144ff88e88", "id": "08121399-0956-4b48-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients OCTINOXATE.............. 4.0% TITANIUM DIOXIDE. 11.5% ZINC OXIDE................. 1.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•DIPHENYLSILOXY PHENYL TRIMETHICONE•CYCLOPENTASILOXANE•GLYCERIN•CYCLOHEXASILOXANE• BUTYLENE GLYCOL•BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE• MALTITOL•SORBITAN ISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE•TRIMETHYLSILOXYSILICATE• TRIBEHENIN•PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE•DISTEARDIMONIUM HECTORITE• MAGNESIUM SULFATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•DIPHENYL DIMETHICONE• VP/HEXADECENE COPOLYMER•PHENOXYETHANOL•METHYL METHACRYLATE CROSSPOLYMER•MICA (CI 77019)• TRIETHOXYCAPRYLYLSILANE•CERESIN•ALUMINUM HYDROXIDE•SODIUM PCA•UREA•STEARIC ACID• ETHYLHEXYLGLYCERIN•ADENOSINE•TREHALOSE•POLYQUATERNIUM-51•DISODIUM EDTA•DIMETHICONE•SODIUM HYALURONATE•TRIACETIN•CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•ACHYRANTHES FAURIEI ROOT EXTRACT•ACTINIDIA POLYGAMA FRUIT EXTRACT•IMPERATA CYLINDRICA ROOT EXTRACT• POLYPERFLUOROMETHYLISOPROPYL ETHER•OXYGEN•PEG-8•CARBOMER•METHYLPARABEN• POTASSIUM SORBATE•BUTYLPARABEN•ETHYLPARABEN•PROPYLPARABEN• ISOBUTYLPARABEN•FRAGRANCE(PARFUM)•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin. aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating. 1. Pump 1 – 2 times to release the formula. 2. After skin care, apply evenly onto face in a light tapping motion using the enclosed CC puff. 3. Do the same for the touch-ups" ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AURA COLOR CONTROL 32800676 octinoxate, titanium dioxide and zinc oxide OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun May stain or damage some fabrics or surfaces" ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC CREAM AURA COLOR CONTROL SUNSCREEN CREAM (REFILL) SPF30 03 MEDIUM BEIGE FACE IT CC CREAM is a color-controlling cream that brightens your complexion and keeps your morning makeup intact without any darkening. FACE it Image-label-32800676-rev" ], "set_id": "08121399-0957-4b48-e054-00144ff88e88", "id": "08121399-0958-4b48-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients OCTINOXATE................ 4.0% TITANIUM DIOXIDE... 11.5% ZINC OXIDE................... 1.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CYCLOPENTASILOXANE•BUTYLENE GLYCOL•CETYL ETHYLHEXANOATE•METHYL TRIMETHICONE• DIPHENYLSILOXY PHENYL TRIMETHICONE•NIACINAMIDE•DIMETHICONE•SILICA•TROMETHAMINE• CYCLOHEXASILOXANE•PEG-10 DIMETHICONE•DISTEARDIMONIUM HECTORITE•POLYMETHYL METHACRYLATE• SORBITAN ISOSTEARATE•DIMETHICONE CROSSPOLYMER•HEXYL LAURATE•METHYL METHACRYLATE CROSSPOLYMER• DIMETHICONE/PEG-10/15 CROSSPOLYMER•CAPRYLIC/CAPRIC GLYCERIDES•MAGNESIUM SULFATE•ALUMINUM HYDROXIDE•STEARIC ACID•MICA•ETHYLHEXYL TRIAZONE•METHYLPARABEN•PROPYLENE CARBONATE• TRIETHOXYCAPRYLYLSILANE•DISTEARYLDIMONIUM CHLORIDE•POLYESTER-1•SILICA DIMETHYL SILYLATE• ETHYLPARABEN•DIMETHICONOL•ADENOSINE•DIPROPYLENE GLYCOL•SODIUM CITRATE•ALUMINA• POLYPERFLUOROMETHYLISOPROPYL ETHER•TOCOPHEROL•CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT•CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT•FRAGRANCE•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away" ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin. aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hoursUse a water-resistant sunscreen if swimming or sweating. At the final stage of skincare, smooth out the CC cream onto entire face following the skin texture. Recommended to pump only once per application to release an adequate amount. Pump gently to avoid any spatter." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT SMART COLOR CONTROL 32800677 ensulizole, titanium dioxide and zinc oxide ENSULIZOLE ENSULIZOLE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun May stain or damage some fabrics or surfaces" ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC CREAM AURA COLOR CONTROL SUNSCREEN CREAM (REFILL) SPF30 02 NATURAL BEIGE FACE IT CC CREAM is a color-controlling cream that brightens your complexion and keeps your morning makeup intact without any darkening. FACE it Image-label-32800677-rev" ], "set_id": "0812c2b7-a914-3252-e054-00144ff88e88", "id": "0812c2b7-a915-3252-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients ENSULIZOLE.............. 2.8% TITANIUM DIOXIDE.. 6.6% ZINC OXIDE.............. 10.6%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•DIPHENYLSILOXY PHENYL TRIMETHICONE•CYCLOPENTASILOXANE•GLYCERIN•CYCLOHEXASILOXANE• BUTYLENE GLYCOL•BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE•MALTITOL•SORBITAN ISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE• TRIMETHYLSILOXYSILICATE•TRIBEHENIN•PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE• DISTEARDIMONIUM HECTORITE•MAGNESIUM SULFATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER• METHYL METHACRYLATE CROSSPOLYMER•DIPHENYL DIMETHICONE•VP/HEXADECENE COPOLYMER• PHENOXYETHANOL•TRIETHOXYCAPRYLYLSILANE•CERESIN•ALUMINUM HYDROXIDE•STEARIC ACID• ETHYLHEXYLGLYCERIN•ADENOSINE•DIMETHICONE•DISODIUM EDTA•SODIUM PCA•SODIUM HYALURONATE• UREA•TREHALOSE•POLYQUATERNIUM-51•CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•ACHYRANTHES FAURIEI ROOT EXTRACT•ACTINIDIA POLYGAMA FRUIT EXTRACT•IMPERATA CYLINDRICA ROOT EXTRACT• POLYPERFLUOROMETHYLISOPROPYL ETHER•OXYGEN•PEG-8•CARBOMER• METHYLPARABEN•POTASSIUM SORBATE•BUTYLPARABEN•ETHYLPARABEN• PROPYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE(PARFUM)•MICA (CI 77019)• IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin. aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating. 1. After skincare, open the case and press the button 1 – 2 times to release the formula. 2. Tap lightly onto skin using CC puff." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AQUA UV COLOR CONTROL 32800773 octinoxate, titanium dioxide and zinc oxide ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun May stain or damage some fabrics or surfaces" ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC AQUA UV COLOR CONTROL SUNSCREEN CREAM SPF50 02 NATURAL BEIGE FACE IT AQUA UV CC is a color control cream that provides sun protection and goes on with cooling sensation. FACE it Image-label-32800773-rev" ], "set_id": "08136a1f-5a35-01bb-e054-00144ff88e88", "id": "08136a1f-5a36-01bb-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Octinoxate.............. 4.0 % Titanium Dioxide 11.5 % Zinc Oxide.............. 1.0 %" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•DIPHENYLSILOXY PHENYL TRIMETHICONE•CYCLOPENTASILOXANE•GLYCERIN•CYCLOHEXASILOXANE• BUTYLENE GLYCOL•BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE• MALTITOL•SORBITAN ISOSTEARATE•OCTYLDODECANOL•CAPRYLYL METHICONE•TRIMETHYLSILOXYSILICATE• TRIBEHENIN•PENTYLENE GLYCOL•PEG-10 DIMETHICONE•HEXYL LAURATE•DISTEARDIMONIUM HECTORITE• MAGNESIUM SULFATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•METHYL METHACRYLATE CROSSPOLYMER•DIPHENYL DIMETHICONE•VP/HEXADECENE COPOLYMER•PHENOXYETHANOL• TRIETHOXYCAPRYLYLSILANE•CERESIN•ALUMINUM HYDROXIDE•STEARIC ACID•ETHYLHEXYLGLYCERIN•ADENOSINE• DIMETHICONE•DISODIUM EDTA•SODIUM PCA•SODIUM HYALURONATE•UREA•TREHALOSE•POLYQUATERNIUM-51• CITRUS RETICULATA (TANGERINE) PEEL EXTRACT•ACHYRANTHES FAURIEI ROOT EXTRACT•ACTINIDIA POLYGAMA FRUIT EXTRACT•IMPERATA CYLINDRICA ROOT EXTRACT•POLYPERFLUOROMETHYLISOPROPYL ETHER•OXYGEN•PEG-8•CARBOMER•METHYLPARABEN•POTASSIUM SORBATE•BUTYLPARABEN• ETHYLPARABEN•PROPYLPARABEN•ISOBUTYLPARABEN•FRAGRANCE(PARFUM)• MICA (CI 77019)•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away ." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin. aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating. 1. After skincare, open the case and press the button 1 – 2 times to release the formula. 2. Tap lightly onto skin using CC puff." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACE IT AQUA UV COLOR CONTROL 32800789 octinoxate, titanium dioxide and zinc oxide TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE WATER" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. / Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC AQUA UV COLOR CONTROL SUNSCREEN CREAM (REFILL) SPF50 01 RADIANT BEIGE FACE IT AQUA UV CC is a color control cream that provides sun protection and goes on with cooling sensation. FACE it Image-label-32800789-rev" ], "set_id": "0813c3dd-9a1a-174b-e054-00144ff8d46c", "id": "0813c3dd-9a1b-174b-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE............. 4.0% TITANIUM DIOXIDE 11.5% ZINC OXIDE ................1.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CYCLOPENTASILOXANE•CYCLOHEXASILOXANE•PHENYL TRIMETHICONE•GLYCERIN•BUTYLENE GLYCOL DICAPRYLATE/ DICAPRATE•DIMETHICONE•BUTYLENE GLYCOL•PEG-8• NIACINAMIDE•CETYL PEG/PPG-10/1 DIMETHICONE•PENTYLENE GLYCOL•SODIUM CHLORIDE•DICAPRYLYL CARBONATE• SORBITAN ISOSTEARATE•DISTEARDIMONIUM HECTORITE• C30-45 ALKYLDIMETHYLSILYL POLYPROPYLSILSESQUIOXANE• PHENOXYETHANOL•DIMETHICONE CROSSPOLYMER• TRIETHOXYCAPRYLYLSILANE•ALUMINUM HYDROXIDE•STEARIC ACID•ETHYLHEXYLGLYCERIN•ADENOSINE•DISODIUM EDTA• VITIS VINIFERA (GRAPE) FRUIT EXTRACT•OENOTHERA BIENNIS (EVENING PRIMROSE) OIL•ONSEN-SUI•SODIUM PCA•UREA• POLYPERFLUOROMETHYLISOPROPYL ETHER•LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT•IMPERATA CYLINDRICA ROOT EXTRACT•TREHALOSE•POLYQUATERNIUM-51• CITRUS RETICULATA (TANGERINE) PEEL EXTRACT• ACHYRANTHES FAURIEI ROOT EXTRACT•SODIUM HYALURONATE•TRIACETIN•CAPRYLYL GLYCOL•1,2-HEXANEDIOL• CARBOMER•METHYLPARABEN•POTASSIUM SORBATE•OXYGEN• BUTYLPARABEN•ETHYLPARABEN•PROPYLPARABEN• ISOBUTYLPARABEN•FRAGRANCE(PARFUM)• MICA (CI 77019)•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Dispense an adequate amount at the last stage of your skincare and apply evenly on the face. To keep your face looking fresh, use with Face it Aura CC Cream." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "FACET IT PURE COLOR CONTROL 32800851 octinoxate, titanium dioxide and zinc oxide cream OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun May stain or damage some fabrics or surfaces", "Other Information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "COLOR CONTROL CC CREAM PURE CC SUNSCREEN CREAM SPF30 02 NATURAL BEIGE Image-label-32800851-rev" ], "set_id": "0813c3dd-9a24-174b-e054-00144ff8d46c", "id": "0813c3dd-9a25-174b-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE 4.0% TITANIUM DIOXIDE 10.2%, ZINC OXIDE 1.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients TALC•SILICA•NYLON-12•DIISOSTEARYL MALATE•PENTAERYTHRITYL TETRAISOSTEARATE•HYDROGENATED POLY(C6-14 OLEFIN•METHICONE• CAPRYLIC/CAPRIC TRIGLYCERIDE•DIMETHICONE•DEA-C8-18 PERFLUOROALKYLETHYL PHOSPHATE•HYDROGENATED LECITHIN• METHYLPARABEN•FRAGRANCE(PARFUM)•PROPYLPARABEN• MONTMORILLONITE•ALUMINUM STARCH OCTENYLSUCCINATE• HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER•WATER•BUTYLENE GLYCOL•ASPALATHUS LINEARIS EXTRACT•LILIUM CANDIDUM FLOWER EXTRACT• BORAGO OFFICINALIS EXTRACT•SALVIA OFFICINALIS (SAGE) LEAF EXTRACT• CENTAUREA CYANUS FLOWER EXTRACT•ANTHEMIS NOBILIS FLOWER EXTRACT•MICA (CI 77019)•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away" ], "when_using": [ "Directions •Apply generously and evenly 15 minutes before sun exposure. •Children under 6 months of age: Ask a doctor •Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. •Reapply at least every 2 hours. •Use a water-resistant sunscreen if swimming or sweating. •Apply onto face in a light patting motion with enclosed puff. For contours around the eyes and nose, apply with extra care." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "PHYTOGENIC INFINTE EX 37100452 octinoxate, titanium dioxide powder OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE MICA" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun May stain or damage some fabrics or surfaces" ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "PHYTO GENIC Infinite EX NB25 sunscreen powder foundation SPF20 Image-label-37100152-rev" ], "set_id": "08150e7f-d6de-4da6-e054-00144ff8d46c", "id": "08150e7f-d6df-4da6-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients OCTINOXATE 2.0%, TITANIUM DIOXIDE 14.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients TALC•SILICA•NYLON-12•DIISOSTEARYL MALATE•PENTAERYTHRITYL TETRAISOSTEARATE•HYDROGENATED POLY(C6-14 OLEFIN•METHICONE• CAPRYLIC/CAPRIC TRIGLYCERIDE•DIMETHICONE•DEA-C8-18 PERFLUOROALKYLETHYL PHOSPHATE•HYDROGENATED LECITHIN• METHYLPARABEN•FRAGRANCE(PARFUM)•PROPYLPARABEN•MONTMORILLONITE• ALUMINUM STARCH OCTENYLSUCCINATE•HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER•WATER•BUTYLENE GLYCOL•ASPALATHUS LINEARIS EXTRACT• LILIUM CANDIDUM FLOWER EXTRACT•BORAGO OFFICINALIS EXTRACT•SALVIA OFFICINALIS (SAGE) LEAF EXTRACT•CENTAUREA CYANUS FLOWER EXTRACT• ANTHEMIS NOBILIS FLOWER EXTRACT•MICA (CI 77019)• IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. •Children under 6 months of age: Ask a doctor •Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. •Reapply at least every 2 hours. •Use a water-resistant sunscreen if swimming or sweating. •Apply onto face in a light patting motion with enclosed puff. For contours around the eyes and nose, apply with extra care." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "PHYTOGENIC INFINTE EX 37100453 octinoxate and titanium dioxide powder MICA Octinoxate Octinoxate Titanium Dioxide Titanium Dioxide" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun May stain or damage some fabrics or surfaces" ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "PHYTOGENIC Infinite EX NB25 sunscreen powder foundation SPF20 Image-label-37100453-rev" ], "set_id": "08150e7f-d6e3-4da6-e054-00144ff8d46c", "id": "08150e7f-d6e4-4da6-e054-00144ff8d46c", "active_ingredient": [ "Active Ingredients Octinoxate 2.0 % Titanium Dioxide 14.0 %," ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CYCLOPENTASILOXANE•BUTYLENE GLYCOL•PEG-10 DIMETHICONE•DIMETHICONE•ARBUTIN•CAPRYLIC/CAPRIC TRIGLYCERIDE•PENTYLENE GLYCOL•GLYCERIN•DISTEARDIMONIUM HECTORITE•MAGNESIUM SULFATE•SORBITAN SESQUIOLEATE• CETYL PEG/PPG-10/1 DIMETHICONE•PHENOXYETHANOL• DIMETHICONE CROSSPOLYMER•METHYL METHACRYLATE CROSSPOLYMER•TRIETHOXYCAPRYLYLSILANE•ALUMINUM HYDROXIDE•FRAGRANCE(PARFUM)•STEARIC ACID• ETHYLHEXYLGLYCERIN•DISODIUM EDTA•CAMELLIA SINENSIS LEAF EXTRACT•DIOSPYROS KAKI LEAF EXTRACT•HONEY EXTRACT• GINKGO BILOBA LEAF EXTRACT•PORTULACA OLERACEA EXTRACT• BETA-GLUCAN•METHYLPARABEN•BUTYLPARABEN• ETHYLPARABEN•ISOBUTYLPARABEN•PROPYLPARABEN• IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. After skincare procedure or makeup-base, apply evenly onto face." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "PHYTOGENIC INFINTE EX FOUNDATION 37100455 titanium dioxide cream WATER TITANIUM DIOXIDE TITANIUM DIOXIDE" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces." ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "PHYTOGENIC INFINITE EX NB25 SUNSCREEN FOUNDATION SPF 20 A long-lasting foundation with GREEN TEA extract. Label" ], "set_id": "08159cb4-dade-4127-e054-00144ff88e88", "id": "08159cb4-dadf-4127-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients TITANIUM DIOXIDE • • • • • • • • 9.3%" ] }, { "effective_time": "20150603", "inactive_ingredient": [ "Inactive Ingredients: Water, Caprylic/Capric, Triglyceride, Cetearyl Alcohol, Glycerin, Polysorbate 60, Dimethicone, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, C10-30 Cholesterol/Lanosterol Esters, Cetyl Ricinoleate, Cetyl Alcohol, Benzyl Alcohol, Polyacrylamide, Cetyl Phosphate, Sodium Metabisulfite, TEA-Stearate, Phenoxyethanol, Magnesium Aluminum Silicate, Cyclopentasiloxane, Triethanolamine, C13-14 Isoparaffin, PEG-10 Soy Sterol, Cyclohexasiloxane, Disodium EDTA, Methylparaben, Retinol, Polysorbate 20, Laureth-7, Bisabolol, Ascorbic Acid, Tocopheryl Acetate, BHT, Ascorbyl Palmitate, Propyl Gallate ________________________________________________________ 150609 AMCOL Health & Beauty Solutions, Inc. DBA 301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com lauren.haase@amcol.com" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. Derma Faith LLC 5701 W. Slaughter Lane A130 #337 Austin, TX 78749 Made in the U.S.A. www.dermafaith.com M050839 This extra-strength formula features patented MICROSPONGE ® Technology to gently, yet effectively help reduce the appearance of dark spots and fine lines." ], "purpose": [ "" ], "warnings": [ "Caution: Do not use if you are pregnant, lactating or planning to become pregnant. Keep out of reach of children. Derma Faith LLC 5701 W. Slaughter Lane A130 #337 Austin, TX 78749 Made in the U.S.A. www.dermafaith.com M050839 This extra-strength formula features patented MICROSPONGE ® Technology to gently, yet effectively help reduce the appearance of dark spots and fine lines." ], "spl_product_data_elements": [ "Vividly Brilliant Perfecting Hydroquinone hydroquinone hydroquinone water medium-chain triglycerides cetostearyl alcohol glycerin polysorbate 60 dimethicone methyl methacrylate/glycol dimethacrylate crosspolymer C10-30 cholesterol/lanosterol esters cetyl ricinoleate cetyl alcohol benzyl alcohol cetyl phosphate sodium metabisulfite trolamine Stearate phenoxyethanol magnesium aluminum silicate cyclomethicone 5 trolamine C13-14 isoparaffin PEG-10 soy sterol cyclomethicone 6 edetate disodium methylparaben retinol polysorbate 20 Laureth-7 levomenol ascorbic acid .alpha.-tocopherol acetate, DL- butylated hydroxytoluene ascorbyl palmitate propyl gallate" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions: Apply a single pump to face in the evening. If you have never used a retinol product before, begin by limiting use to twice a week, gradually increasing frequency to every other night, and then advancing to each evening or as tolerated. Mild redness, peeling and irritation is expected when using this product." ], "spl_unclassified_section": [ "HBS Code (Labeler): FP60402-50.2 Distributor: Derma Faith Human Prescription Drug Active Ingredient: Hydroquinone 4% CARTON TEXT ________________________________________________________ vividly brilliant perfecting lotion derma faith 50 ml/1.7 fl oz vividly brilliant perfecting lotion" ], "do_not_use": [ "Do not use if you are pregnant, lactating or planning to become pregnant." ], "package_label_principal_display_panel": [ "Principal Display Panel - Carton Label vividly brilliant perfecting lotion derma faith 50 ml/1.7 fl oz Principal Display Panel - Carton Label", "Principal Display Panel - Bottle Label vividly brilliant perfecting lotion derma faith 50 ml/1.7 fl oz Principal Display Panel - Bottle Label" ], "indications_and_usage": [ "Use daily sun protection during use of this product. Avoid getting in eyes. If contact occurs, rinse eyes thoroughly with water." ], "set_id": "081cc08d-d9e9-4140-8c67-9b5fd998a5ff", "id": "e5da532f-240f-43de-8a67-30f86c44ede4", "active_ingredient": [ "Active Ingredients: Hydroquinone 4.0%" ] }, { "effective_time": "20141120", "inactive_ingredient": [ "Inactive Ingredients WATER•CYCLOPENTASILOXANE•DIPHENYLSILOXY PHENYL TRIMETHICONE•BUTYLENE GLYCOL• GLYCERIN•NIACINAMIDE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE•CETYL PEG/PPG-10/1 DIMETHICONE•PENTYLENE GLYCOL•DIMETHICONE•SODIUM CHLORIDE•TRIBEHENIN•DISTEARDIMONIUM HECTORITE•SORBITAN ISOSTEARATE•C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER• MICA (CI 77019)•PHENOXYETHANOL•METHYL METHACRYLATE CROSSPOLYMER•POLYESTER-1• ALUMINUM HYDROXIDE•STEARIC ACID•SILICA DIMETHYL SILYLATE•DIMETHICONE CROSSPOLYMER• FRAGRANCE(PARFUM)•TRIETHOXYCAPRYLYLSILANE•ETHYLHEXYLGLYCERIN•ADENOSINE•DISODIUM EDTA•CAMELLIA SINENSIS LEAF EXTRACT•DIOSPYROS KAKI LEAF EXTRACT•HONEY EXTRACT•GINKGO BILOBA LEAF EXTRACT•PORTULACA OLERACEA EXTRACT•BETA-GLUCAN•METHYLPARABEN• BUTYLPARABEN•ETHYLPARABEN•ISOBUTYLPARABEN•PROPYLPARABEN•IRON OXIDES (CI 77491, CI 77492, CI 77499)" ], "purpose": [ "Purpose Sunscreen Sunscreen Sunscreen" ], "warnings": [ "Warnings For external use only. Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children . If product is swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "Directions Apply generously and evenly 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. After basic skincare, apply evenly to the skin. Then pat lightly with the palms for full absorption." ], "questions": [ "Questions or comments? Call 1 (866) 638-8417" ], "spl_product_data_elements": [ "PHYTOGENIC INFINTE 37100457 octinoxate, titanium dioxide and zinc oxide cream ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE WATER" ], "other_safety_information": [ "Other Information Protect the product in this container from excessive heat and direct sun. May stain or damage some fabrics or surfaces" ], "openfda": {}, "version": "1", "spl_unclassified_section": [ "Distributed by: THEFACESHOP NORTH AMERICA, INC. Santa Fe Springs, CA 90670" ], "package_label_principal_display_panel": [ "PHYTO GENIC Infinite EX CC cream SPF 30 PA++ Label" ], "set_id": "0822d47f-2986-6499-e054-00144ff88e88", "id": "0822d47f-2987-6499-e054-00144ff88e88", "active_ingredient": [ "Active Ingredients Octinoxate ................5.0 % Titanium Dioxide......6.1 % Zinc Oxide.................5.0 %" ] }, { "effective_time": "20110825", "inactive_ingredient": [ "Inactive ingredients Aqua (water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis-ethylhexyl hydroxydimethoxy benzylmalonate, dimethicone, tocopheryl acetate, ceteareth-20, silica, methicone, cetearyl alcohol, ceteareth-12, cetyl palmitate, peg-8, propylene glycol, phenoxyethanol, methylparaben, ambrosia peruviana leaf extract, xantham gum, caprylyl glycol, mica, propylparaben, triethoxycaprylylsilane, butylene glycol, helianthus annuus (sunflower) seed extract, ppg-1-peg-9-lauryl glycol ether, chlorphenesin, cyclopentasiloxane, hedera helix (ivy) leaf/stem extract, phytic acid, sodium polyacrylate." ], "purpose": [ "Active Ingredients Purpose Homosalate (5 %) Sunscreen Octinoxate (7 %) Sunscreen Octisalate (5 %) Sunscreen Oxybenzone (4 %) Sunscreen Titanium Dioxide (6.24%) Sunscreen Zinc Oxide (3.88%) Sunscreen" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "warnings": [ "Warnings For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "spl_product_data_elements": [ "LBEL UV DEFENSE 365 Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, and Zinc Oxide Homosalate Homosalate Octinoxate Octinoxate Octisalate Octisalate Oxybenzone Oxybenzone Titanium Dioxide Titanium Dioxide Zinc Oxide Zinc Oxide water dicaprylyl carbonate propylheptyl caprylate glyceryl monostearate potassium cetyl phosphate cyclomethicone 6 glycerin sorbitan monostearate dimethicone polyoxyl 20 cetostearyl ether silicon dioxide cetostearyl alcohol ceteareth-12 cetyl palmitate polyethylene glycol 400 propylene glycol phenoxyethanol methylparaben ambrosia peruviana leaf xanthan gum caprylyl glycol mica propylparaben triethoxycaprylylsilane butylene glycol sunflower seed chlorphenesin cyclomethicone 5 hedera helix top phytic acid" ], "openfda": {}, "version": "1", "dosage_and_administration": [ "Directions Apply smoothly every morning before sun exposure and as needed." ], "spl_unclassified_section": [ "Drug Facts", "Dist. by Ventura Corporation, Ltd, San Juan, Puerto Rico 00926." ], "stop_use": [ "Stop use and ask a doctor if rash and irritation develops and lasts." ], "storage_and_handling": [ "Other information High sun protection product. Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun. Apply the product with your fingertips. Use every morning before exposure to UVA and UVB radiation or whenever needed." ], "active_ingredient_table": [ "
Active Ingredients Purpose
Homosalate (5 %) Sunscreen
Octinoxate (7 %) Sunscreen
Octisalate (5 %) Sunscreen
Oxybenzone (4 %) Sunscreen
Titanium Dioxide (6.24%) Sunscreen
Zinc Oxide (3.88%) Sunscreen
" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton L'BEL UV DÉFENSE 365 oil-free daily protective facial lotion SPF 50 UVB SPF 50 UVA PA +++ 30 ml e (1 fl.oz.) Principal Display Panel - 30 ml Bottle Carton" ], "indications_and_usage": [ "Uses Helps prevent sunburn. higher SPF gives more sunburn protection" ], "set_id": "0873d6a1-55df-415e-8f95-2d08ef7ee84f", "id": "38b1a1b0-a33d-404c-8214-b9cbf57a478c", "purpose_table": [ "
Active Ingredients Purpose
Homosalate (5 %) Sunscreen
Octinoxate (7 %) Sunscreen
Octisalate (5 %) Sunscreen
Oxybenzone (4 %) Sunscreen
Titanium Dioxide (6.24%) Sunscreen
Zinc Oxide (3.88%) Sunscreen
" ], "active_ingredient": [ "Active Ingredients Purpose Homosalate (5 %) Sunscreen Octinoxate (7 %) Sunscreen Octisalate (5 %) Sunscreen Oxybenzone (4 %) Sunscreen Titanium Dioxide (6.24%) Sunscreen Zinc Oxide (3.88%) Sunscreen Uses Helps prevent sunburn. higher SPF gives more sunburn protection" ] } ] }