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NDC 62032-0116-36 NU-DERM SUNFADER 40; 75; 55 mg/g; mg/g; mg/g Details
NU-DERM SUNFADER 40; 75; 55 mg/g; mg/g; mg/g
NU-DERM SUNFADER is a TOPICAL LOTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Obagi Cosmeceuticals LLC. The primary component is HYDROQUINONE; OCTINOXATE; OXYBENZONE.
Product Information
| NDC | 62032-0116 |
|---|---|
| Product ID | 62032-116_4d837819-2705-41b1-a0b0-240cdad9ef47 |
| Associated GPIs | |
| GCN Sequence Number | 059633 |
| GCN Sequence Number Description | hydroquinone/oxyben/octinoxate CREAM (G) 4 %-SPF 15 TOPICAL |
| HIC3 | L9C |
| HIC3 Description | HYPOPIGMENTATION AGENTS |
| GCN | 25364 |
| HICL Sequence Number | 025814 |
| HICL Sequence Number Description | HYDROQUINONE/SUNSCREENS (OXYBENZONE/OCTINOXATE) |
| Brand/Generic | Brand |
| Proprietary Name | NU-DERM SUNFADER |
| Proprietary Name Suffix | Skin Lightener with Sunscreen (SPF 15) PABA FREE |
| Non-Proprietary Name | HYDROQUINONE, OCTINOXATE, and OXYBENZONE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 40; 75; 55 |
| Active Ingredient Units | mg/g; mg/g; mg/g |
| Substance Name | HYDROQUINONE; OCTINOXATE; OXYBENZONE |
| Labeler Name | Obagi Cosmeceuticals LLC |
| Pharmaceutical Class | Depigmenting Activity [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 62032-0116-36 (62032011636)
| NDC Package Code | 62032-116-36 |
|---|---|
| Billing NDC | 62032011636 |
| Package | 57 g in 1 BOTTLE, PLASTIC (62032-116-36) |
| Marketing Start Date | 1984-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e5c450af-958e-41e3-9c2f-fda76b3596f5 Details
DESCRIPTION
Hydroquinone is 1, 4-benzenediol. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designed as p-dihydroxybenzene; the empirical formula is C6H6O2; molecular weight is 110.11 g/mol. The chemical structure is in the diagram below.
Each gram of Obagi Nu-Derm Clear contains:
Active ingredient: Hydroquinone USP, 4% (40 mg/g)
Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, lactic acid, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, propylparaben, saponins, butylparaben
Each gram of Obagi Nu-Derm Blender contains:
Active ingredient: Hydroquinone USP, 4% (40 mg/g)
Inactive ingredients: water, glycerin, cetyl alcohol, PPG-2 myristyl ether propionate, sodium lauryl sulfate, TEA-salicylate, lactic acid, phenyl trimethicone, tocopheryl acetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA, propylparaben, saponins, BHT
Each gram of Obagi Nu-Derm Sunfader contains:
Active ingredients: Hydroquinone USP, 4% (40 mg/g); Octinoxate USP, 7.5%; Oxybenzone USP, 5.5%
Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, BHT, saponins, propylparaben, butylparaben
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 sunblocking agents or sunscreen agents contained in Obagi Nu-Derm Sunfader and Obagi Nu-Derm Sun Shield Matte Broad Spectrum SPF 50.
INDICATIONS AND USAGE
CONTRAINDICATIONS
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. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, product should be discontinued and physician consulted. 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.
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.
ADVERSE REACTIONS
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, a sunblocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent darkening from reoccurring.
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
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 3
PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 5
PRINCIPAL DISPLAY PANEL - 57 g Bottle Label - 6
INGREDIENTS AND APPEARANCE
| NU-DERM CLEAR
SKIN BLEACHING AND CORRECTOR
hydroquinone cream |
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| NU-DERM BLENDER
SKIN LIGHTENER AND BLENDING
hydroquinone cream |
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| NU-DERM SUNFADER
SKIN LIGHTENER WITH SUNSCREEN (SPF 15) PABA FREE
hydroquinone, octinoxate, and oxybenzone lotion |
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| Labeler - Obagi Cosmeceuticals LLC (790553353) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| PureTek Corporation | 785961046 | MANUFACTURE(62032-101, 62032-100, 62032-116) , LABEL(62032-101, 62032-100, 62032-116) , PACK(62032-101, 62032-100, 62032-116) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| G.S. COSMECEUTICAL USA, INC. | 017014734 | MANUFACTURE(62032-101, 62032-100) | |