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NU-DERM system NORMAL-oily

OBAGI NU-DERM SYSTEM

Approved
Approval ID

48a6f977-d7b8-4da4-8bab-b3b8df5347c3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 26, 2023

Manufacturers
FDA

OBAGI COSMECEUTICAL LLC

DUNS: 790553353

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Hydroquinone, Homosalate, Octisalate, and Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62032-533
Product Classification
G
Generic Name
Hydroquinone, Homosalate, Octisalate, and Zinc Oxide
Product Specifications
Effective DateJanuary 26, 2023
FDA Product Classification

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 1/26/2023

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 C6H6O2; molecular weight is 110.11 g/mol. The chemical structure is in the diagram below.

Chemical Structure

C6H6O2

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)

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 1/26/2023

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.

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NU-DERM system NORMAL-oily - FDA Drug Approval Details