{
"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": "2026-06-03",
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{
"spl_product_data_elements": [
"Obagi Skintrinsiq Clarifiying Protocol salicylic acid, titanium dioxide, and zinc oxide Obagi Nu-Derm Gentle Cleanser ALOE VERA LEAF APRICOT KERNEL OIL BORAGO OFFICINALIS SEED BUTYLPARABEN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) COCAMIDOPROPYL BETAINE DIETHYLENE GLYCOL MONOETHYL ETHER ETHYLPARABEN FD&C YELLOW NO. 5 GLYCERETH-7 GLYCERIN ISOBUTYLPARABEN METHYLPARABEN OLEYL LACTATE PANTHENOL PHENOXYETHANOL PROPYLPARABEN SAGE SODIUM LAURETH-3 SULFATE SODIUM LAUROYL OAT AMINO ACIDS TROLAMINE WATER Obagi Nu-Derm Toner ALLANTOIN ALOE VERA LEAF BORAGO OFFICINALIS SEED CALENDULA OFFICINALIS FLOWER DMDM HYDANTOIN FD&C BLUE NO. 1 GLYCERIN HAMAMELIS VIRGINIANA TOP WATER IODOPROPYNYL BUTYLCARBAMATE POLYSORBATE 80 POTASSIUM ALUM SAGE SODIUM PYRROLIDONE CARBOXYLATE WATER CLENZIDERM PORE THERAPY ACNE TREATMENT SALICYLIC ACID 3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL ALCOHOL BENZYL ALCOHOL CHAMOMILE DIETHYLENE GLYCOL MONOETHYL ETHER EXT. D&C VIOLET NO. 2 GLYCERIN MENTHOL, UNSPECIFIED FORM MENTHYL LACTATE, (-)- WATER SALICYLIC ACID SALICYLIC ACID Obagi Hydrate Facial Moisturizer ALLANTOIN AVOCADO OIL CAESALPINIA SPINOSA RESIN CAPRYLYL GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CETYL ALCOHOL CYCLOMETHICONE 5 DIMETHICONE, UNSPECIFIED DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL MONOSTEARATE HEXYLENE GLYCOL LAURETH-12 LEVOMENOL MANGIFERA INDICA SEED BUTTER MEDIUM-CHAIN TRIGLYCERIDES PANTHENOL PHENOXYETHANOL SACCHARIDE ISOMERATE SHEA BUTTER SODIUM HYDROXIDE SODIUM STEAROYL GLUTAMATE SOY STEROL SOYBEAN STEARIC ACID TETRAHYDRODIFERULOYLMETHANE TOCOPHEROL WATER SUN SHIELD MINERAL BROAD SPECTRUM SPF 50 SUNSCREEN Titanium Dioxide and Zinc Oxide ALUMINUM OXIDE CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL CETEARYL GLUCOSIDE CETOSTEARYL ALCOHOL DICAPRYLYL CARBONATE GLYCERIN GLYCYRRHIZINATE DIPOTASSIUM MEDIUM-CHAIN TRIGLYCERIDES PENTYLENE GLYCOL POLYHYDROXYSTEARIC ACID (2300 MW) PROPANEDIOL SILICON DIOXIDE SODIUM STEAROYL GLUTAMATE STEARETH-2 STEARETH-21 STEARIC ACID TRIETHOXYCAPRYLYLSILANE TRISODIUM ETHYLENEDIAMINE DISUCCINATE TROPAEOLUM MAJUS FLOWERING TOP WATER XANTHAN GUM TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE"
],
"spl_unclassified_section": [
"Obagi ® Medical CLENZIderm M.D. ® Pore Therapy Drug Facts",
"Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806",
"Obagi™ Sun Shield Mineral Broad Spectrum SPF 50 Sunscreen Drug Facts",
"Distributed by Obagi Cosmeceuticals LLC Long Beach, CA 90806"
],
"active_ingredient": [
"Active ingredient Salicylic Acid 2%",
"Active ingredients Purpose Titanium dioxide 6.2% Sunscreen Zinc oxide 15.6% Sunscreen"
],
"purpose": [
"Purpose Acne treatment",
"Active ingredients Purpose Titanium dioxide 6.2% Sunscreen Zinc oxide 15.6% Sunscreen"
],
"indications_and_usage": [
"Uses or the treatment of acne dries up acne pimples helps prevent new acne pimples",
"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"
],
"warnings": [
"Warnings For external use only 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. 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.",
"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 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 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.",
"When using this product keep out of eyes. Rinse with water to remove."
],
"stop_use": [
"Stop use and ask a doctor if irritation becomes severe.",
"Stop use and ask doctor if rash occurs"
],
"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.",
"Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
],
"dosage_and_administration": [
"Directions Cleanse the skin thoroughly before applying this product. Shake product well before use. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.",
"Directions apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: 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"
],
"storage_and_handling": [
"Other information store away from heat and direct sunlight store at controlled room temperature: 15°–25°C (59°–77°F)",
"Other information store at controlled room temperature: 15°C–25°C (59°F–77°F) protect this product from excessive heat and direct sun"
],
"inactive_ingredient": [
"Inactive ingredients benzyl alcohol, chamomilla recutita (matricaria) flower extract, ethoxydiglycol, ext. violet 2, fragrance, glycerin, menthol, menthoxypropanediol, menthyl lactate, SD alcohol 40-B, water (aqua)",
"Inactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Pentylene Glycol, Steareth-2, Glycerin, Silica, Polyhydroxystearic Acid, Steareth-21, Cetearyl Alcohol, Propanediol, Alumina, Stearic Acid, Sodium Stearoyl Glutamate, Caprylyl Glycol, Triethoxycaprylylsilane, Cetearyl Glucoslde, Xanthan Gum, Dipotassium Glycyrrhizate,Trisodium Ethylenediamine Disuccinate, Caprylhydroxamic Acid, Tropaeolum Majus Flower/Leaf/Stem Extract"
],
"questions": [
"Questions or comments? 1.800.636.7546 Monday–Friday 9a.m.–4p.m. Pacific Time",
"Questions or comments? 1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. Pacific Time"
],
"active_ingredient_table": [
"| Active ingredients | Purpose |
|---|
| Titanium dioxide 6.2% | Sunscreen |
| Zinc oxide 15.6% | Sunscreen |
"
],
"purpose_table": [
"| Active ingredients | Purpose |
|---|
| Titanium dioxide 6.2% | Sunscreen |
| Zinc oxide 15.6% | Sunscreen |
"
],
"do_not_use": [
"Do not use on damaged or broken skin"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - Kit Carton SKINTRINSIQ™ CLARIFYING PROTOCOL KIT INCLUDES: 60 Tips Obagi Nu-Derm ® Gentle Cleanser, 2 FL. OZ. Obagi Nu-Derm ® Toner, 2 FL. OZ. CLENZIderm M.D. ® Pore Therapy, 5 FL. OZ. Obagi Hydrate ® Facial Moisturizer, 1.7 OZ. Obagi Sun Shield™ Mineral Broad Spectrum SPF 50 Sunscreen, 3 OZ. OBAGI ® PRINCIPAL DISPLAY PANEL - Kit Carton",
"PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label OBAGI ® MEDICAL CLENZIderm M.D. ® Pore Therapy Salicylic Acid 2% Acne Treatment 5 FL. OZ. (148 mL) PRINCIPAL DISPLAY PANEL - 148 mL Bottle Label",
"PRINCIPAL DISPLAY PANEL - 85 g Tube Carton OBAGI™ MEDICAL Sun Shield Broad Spectrum SPF 50 MINERAL Sunscreen Lotion PA++++ Non-comedogenic Dermatologist Tested Net wt. 3 oz. (85 g) PRINCIPAL DISPLAY PANEL - 85 g Tube Carton"
],
"set_id": "08ba9ea8-73fd-472b-9cc4-67df167352ec",
"id": "a9c17c57-a3af-43d6-9db3-56fb8e28894b",
"effective_time": "20250321",
"version": "3",
"openfda": {
"application_number": [
"M020"
],
"brand_name": [
"Obagi Skintrinsiq Clarifiying Protocol"
],
"generic_name": [
"SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE"
],
"manufacturer_name": [
"Obagi Cosmeceuticals LLC"
],
"product_ndc": [
"62032-909"
],
"product_type": [
"HUMAN OTC DRUG"
],
"rxcui": [
"251577",
"1235208"
],
"spl_id": [
"a9c17c57-a3af-43d6-9db3-56fb8e28894b"
],
"spl_set_id": [
"08ba9ea8-73fd-472b-9cc4-67df167352ec"
],
"package_ndc": [
"62032-909-09",
"62032-612-04",
"62032-811-09"
],
"is_original_packager": [
true
]
}
}
]
}