{
"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": [
"nu-derm system normal-dry skin transformation Hydroquinone, Octisalate and Zinc Oxide NU-DERM GENTLE CLEANSER WATER GLYCERIN PHENOXYETHANOL METHYLPARABEN PROPYLPARABEN BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) SODIUM LAUROYL OAT AMINO ACIDS COCAMIDOPROPYL BETAINE SODIUM LAURETH-3 SULFATE ALOE VERA LEAF GLYCERETH-7 PANTHENOL DIETHYLENE GLYCOL MONOETHYL ETHER TROLAMINE SAGE FD&C YELLOW NO. 5 APRICOT KERNEL OIL OLEYL LACTATE YELLOW NU-DERM TONER WATER GLYCERIN HAMAMELIS VIRGINIANA TOP WATER SODIUM PYRROLIDONE CARBOXYLATE DMDM HYDANTOIN IODOPROPYNYL BUTYLCARBAMATE POTASSIUM ALUM PANTHENOL SAGE CALENDULA OFFICINALIS FLOWER POLYSORBATE 80 ALLANTOIN ALOE VERA LEAF FD&C BLUE NO. 1 BLUE NU-DERM CLEAR Skin Bleaching and Corrector HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM BUTYLPARABEN STEARYL ALCOHOL SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE NU-DERM EXFODERM Skin Smoothing WATER GLYCERIN METHYLPARABEN PROPYLPARABEN POLYSORBATE 60 CETOSTEARYL ALCOHOL STEARETH-20 CANOLA OIL ISOHEXADECANE MAGNESIUM ALUMINUM SILICATE CETYL ALCOHOL FYTIC ACID GLYCERYL MONOSTEARATE PEG-100 STEARATE DIMETHICONE PEG-150 STEARATE PHENOXYETHANOL BUTYLPARABEN ETHYLPARABEN ISOBUTYLPARABEN POTASSIUM CETYL PHOSPHATE XANTHAN GUM .ALPHA.-TOCOPHEROL ACETATE GLYCERETH-7 DIETHYLENE GLYCOL MONOETHYL ETHER BIS-DIGLYCERYL POLYACYLADIPATE-2 SODIUM HYDROXIDE NU-DERM HYDRATE FACIAL MOISTURIZER WATER GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES SODIUM HYDROXIDE CAESALPINIA SPINOSA RESIN SHEA BUTTER DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CYCLOMETHICONE 5 CETYL ALCOHOL SACCHARIDE ISOMERATE DIMETHICONE TOCOPHEROL LAURETH-12 PHENOXYETHANOL ETHYLHEXYLGLYCERIN STEARIC ACID AVOCADO OIL SOY STEROL CAPRYLYL GLYCOL LEVOMENOL HEXYLENE GLYCOL TETRAHYDRODIFERULOYLMETHANE PANTHENOL MANGIFERA INDICA SEED BUTTER SODIUM STEAROYL GLUTAMATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ALLANTOIN GLYCERYL MONOSTEARATE WHITE NU-DERM BLENDER Skin Lightener and Blending HYDROQUINONE HYDROQUINONE HYDROQUINONE EDETATE DISODIUM PPG-2 MYRISTYL ETHER PROPIONATE TROLAMINE SALICYLATE SODIUM LAURYL SULFATE CETYL ALCOHOL GLYCERIN LACTIC ACID, UNSPECIFIED FORM .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID SODIUM METABISULFITE WATER METHYLPARABEN PROPYLPARABEN BUTYLATED HYDROXYTOLUENE PHENYL TRIMETHICONE NU-DERM SUN-SHIELD MATTE BROAD SPECTRUM SPF 50 SUNSCREEN HOMOSALATE, OCTINOXATE AND ZINC OXIDE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE ZINC OXIDE ZINC OXIDE WATER GLYCERIN Hydroxyacetophenone XANTHAN GUM Sodium Chloride Sodium Hydroxide Octyldodecyl Neopentanoate Triethoxycaprylylsilane C15-19 Alkane Disteardimonium Hectorite Polyglyceryl-2 Isostearate Sorbitan Olivate DIMETHICONE 1,2-HEXANEDIOL CAPRYLYL GLYCOL EDETATE DISODIUM Candelilla Wax Yellow Wax POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) SILICON DIOXIDE"
],
"spl_unclassified_section": [
"OBAGI NU-DERM ®",
"Rx only For external use only",
"Manufactured for: Obagi Cosmeceuticals LLC, Long Beach, CA 90806 All products/brand names, whether designated by notice or not (®/TM), are trademarks of Obagi Cosmeceuticals LLC and/or its affiliates. ©2019 Obagi Cosmeceuticals LLC. All rights reserved. www.obagi.com Revised 01/2019 9458404 Obagi Nu-Derm ® Clear (Hydroquinone, USP 4%) Skin Bleaching Cream Obagi Nu-Derm Blender ® (Hydroquinone, USP 4%) Skin Bleaching Cream Obagi Nu-Derm Sunfader ® (Hydroquinone, USP 4%; Octinoxate, USP 7.5%; Oxybenzone, USP 5.5%) Skin Bleaching Cream with Sunscreens",
"Sun Shield Matte Broad Spectrum SPF 50 Net wt. 3 oz. (85 g) AM",
"Drug Facts",
"Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806"
],
"description": [
"DESCRIPTION Hydroquinone, USP 4% is 1, 4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C 6 H 6 O 2 ; molecular weight is 110.11 g/mol. The chemical structure is in the diagram below. Chemical Structure Each gram of Obagi Nu-Derm ® Clear contains: ACTIVE: Hydroquinone, USP 4% (40 mg/g) INACTIVES: ascorbic acid, BHT, butylparaben, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tocopheryl acetate, water (aqua) Each gram of Obagi Nu-Derm Blender ® contains: ACTIVE: Hydroquinone, USP 4% (40 mg/g) INACTIVES: ascorbic acid, BHT, cetyl alcohol, disodium EDTA, glycerin, lactic acid, methylparaben, phenyl trimethicone, PPG-2 myristyl ether propionate, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, TEA-salicylate, tocopheryl acetate, water (aqua) Each gram of Obagi Nu-Derm ® Sunfader ® contains: ACTIVES: Hydroquinone, USP 4% (40mg/g); Octinoxate, USP 7.5%; Oxybenzone, USP 5.5% INACTIVES: ascorbic acid, BHT, butylparaben, cetyl alcohol, disodium EDTA, glycerin, methylparaben, propylparaben, saponins, sodium lauryl sulfate, sodium metabisulfite, stearyl alcohol, tocopheryl acetate, water (aqua)"
],
"clinical_pharmacology": [
"CLINICAL PHARMACOLOGY Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3, 4-dihydroxyphenylalanine (DOPA) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas, which may be prevented by the use of sunscreen agents such as those contained in Obagi Nu-Derm Sunfader ® and Obagi Nu-Derm ® Sun Shield Matte Broad Spectrum SPF 50."
],
"indications_and_usage": [
"INDICATIONS AND USAGE For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.",
"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"
],
"contraindications": [
"CONTRAINDICATIONS People with prior history of sensitivity or allergic reaction to this product or any of its ingredients should not use it. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established."
],
"warnings": [
"WARNINGS Hydroquinone is a skin-bleaching agent, which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this product. Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check within 24 hours. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Close patient supervision is recommended. WARNINGS: Avoid contact with eyes, nose, mouth and lips. In case of accidental contact, patient should rinse thoroughly with water and contact a physician. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.",
"Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."
],
"precautions": [
"PRECAUTIONS (also see WARNINGS ): Treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation, which does not preclude treatment. PREGNANCY CATEGORY C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated. NURSING MOTHERS It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother. PEDIATRIC USAGE Safety and effectiveness in children below the age of 12 years have not been established."
],
"pregnancy": [
"PREGNANCY CATEGORY C Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should be used on pregnant women only when clearly indicated."
],
"nursing_mothers": [
"NURSING MOTHERS It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother."
],
"pediatric_use": [
"PEDIATRIC USAGE Safety and effectiveness in children below the age of 12 years have not been established."
],
"adverse_reactions": [
"ADVERSE REACTIONS No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the product should be discontinued and the physician notified immediately. To report SUSPECTED ADVERSE REACTIONS, contact Obagi Cosmeceuticals LLC, at 1-800-636-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."
],
"dosage_and_administration": [
"DOSAGE AND ADMINISTRATION A thin application should be applied once or twice daily or as directed by a physician. If no improvement is seen after three (3) months of treatment, use of this product should be discontinued. Sun exposure should be limited by using a sunscreen agent or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.",
"Directions 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: Ask a doctor"
],
"how_supplied": [
"HOW SUPPLIED Obagi Nu-Derm ® Clear is available as follows: Net wt. 2 oz. (57 g) bottle NDC 62032-101-36 Obagi Nu-Derm Blender ® is available as follows: Net wt. 2 oz. (57 g) bottle NDC 62032-100-36 Net wt. 1 oz. (28 g) bottle NDC 62032-100-10 Obagi Nu-Derm Sunfader ® is available as follows: Net wt. 2 oz. (57 g) bottle NDC 62032-116-36 Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight. 1-800-636-7546 Figure"
],
"storage_and_handling": [
"Store at controlled room temperature: 15° to 25°C (59° to 77°F). Keep out of direct sunlight. 1-800-636-7546 Figure",
"Other information store at controlled room temperature: 15°C–25°C (59°F–77°F) protect this product from excessive heat and direct sun"
],
"active_ingredient": [
"Active ingredients Purpose Homosalate 10% Sunscreen Octisalate 5% Sunscreen Zinc Oxide 16.5% Sunscreen"
],
"active_ingredient_table": [
"| Active ingredients | Purpose |
|---|
| Homosalate 10% | Sunscreen |
| Octisalate 5% | Sunscreen |
| Zinc Oxide 16.5% | Sunscreen |
"
],
"purpose": [
"Active ingredients Purpose Homosalate 10% Sunscreen Octisalate 5% Sunscreen Zinc Oxide 16.5% Sunscreen"
],
"purpose_table": [
"| Active ingredients | Purpose |
|---|
| Homosalate 10% | Sunscreen |
| Octisalate 5% | Sunscreen |
| Zinc Oxide 16.5% | Sunscreen |
"
],
"do_not_use": [
"Do not use on damaged or broken skin"
],
"stop_use": [
"Stop use and ask a doctor if rash occurs"
],
"when_using": [
"When using this product keep out of eyes. Rinse with water to remove."
],
"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."
],
"inactive_ingredient": [
"Inactive ingredients Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone"
],
"questions": [
"Questions or comments? 1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. Pacific Time"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - Kit Carton NDC# 62032-529-06 OBAGI ® MEDICAL NORMAL DRY Skin Transformation Kit Principal Display Panel - Kit Carton"
],
"set_id": "7548658a-5371-4aed-baf8-e5dc54262223",
"id": "ed79404d-956a-4f71-b348-3e89930fac3d",
"effective_time": "20250314",
"version": "3",
"openfda": {
"brand_name": [
"nu-derm system normal-dry skin transformation"
],
"generic_name": [
"HYDROQUINONE, OCTISALATE AND ZINC OXIDE"
],
"manufacturer_name": [
"OBAGI COSMECEUTICAL LLC"
],
"product_ndc": [
"62032-529"
],
"product_type": [
"HUMAN PRESCRIPTION DRUG"
],
"rxcui": [
"197795"
],
"spl_id": [
"ed79404d-956a-4f71-b348-3e89930fac3d"
],
"spl_set_id": [
"7548658a-5371-4aed-baf8-e5dc54262223"
],
"package_ndc": [
"62032-529-06",
"62032-101-36",
"62032-100-36",
"62032-141-10"
],
"is_original_packager": [
true
]
}
}
]
}