The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Obagi Nu-Derm Sunfader is intended for daytime use as it contains sunscreen agents.
A thin application should be applied to the affected area 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 sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent repigmentation.
Rx Only
FOR EXTERNAL USE ONLY
Hydroquinone is 1,4-benzenediol. Hydroquinone occurs as fine, white needles. The drug is freely soluble in water and in alcohol. Chemically, hydroquinone is designated as p-dihydroxybenzene; the empirical formula is C6 H6 O2; molecular weight is 110.0.
Each gram of Obagi Nu-Derm Blender contains Hydroquinone USP 40 mg/gm in a base of purified 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, saponins, disodium EDTA, BHT, and propylparaben.
Each gram of Obagi Nu-Derm Clear contains Hydroquinone USP 40 mg/gm in a base of purified water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, lactic acid, saponins, disodium EDTA, methylparaben, BHT, propylparaben, and butylparaben.
Each gram of Obagi Nu-Derm Sunfader contains Hydroquinone USP 40 mg/gm, Octinoxate USP, 7.5%, and Oxybenzone USP, 5.5%, in a base of purified water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol, tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, methylparaben, saponins, propylparaben, BHT, and butylparaben.
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.
The gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. Obagi Nu-Derm Sunfader is intended for daytime use as it contains sunscreen agents.
Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.
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 medication.
Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended.
Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with water and contact physician. A bitter taste and anesthetic effect may occur if applied to lips.
Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. Obagi Sunfader is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.
Contains sodium metabisulfite, a sulfite that may cause serious allergic type reactions (e.g., hives, itching, wheezing, anaphylaxis, severe asthma attacks) in certain susceptible persons.
(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.
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.
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.
Safety and effectiveness in children below the age of 12 years have not been established.
No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur, in which case the medication should be discontinued and the physician notified immediately.
A thin application should be applied to the affected area 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 sun blocking agent, or protective clothing to cover bleached skin when using and after using this product in order to prevent repigmentation.
Obagi Nu-Derm Blender is available as follows:
| 2 oz. (57 gm) bottle | NDC 62032-100-36 |
| 1 oz. (28.5 gm) bottle | NDC 62032-100-10 |
Obagi Nu-Derm Clear is available as follows:
| 2 oz. (57 gm) bottle | NDC 62032-101-36 |
| 1 oz. (28.5 gm) bottle | NDC 62032-101-10 |
Obagi Nu-Derm Sunfader is available as:
| 2 oz. (57 gm) bottle | NDC 62032-116-36 |
Store at 25°C (77°F); excursion permitted to 15°C-30°C (59°F-86°F).
OMP, Inc.
Long Beach, CA 90802
USA
1-800-636-7546
Rev. 8/03
OBAGI®
SYSTEM
NU-DERM®
skin transformation system
starter set
normal/dry
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROQUINONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 444b3e50-f226-46ef-bfca-2e7035d140cd | Product name | 1 | 20190611 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 597b1cfd-7b31-5048-62be-ca5cd740da2f | Product name | 1 | 20140508 |
| 85490a6b-2306-6bf2-c51b-eb63537dc2da | Product name | 1 | 20140508 |
| ec2149b3-5c6d-5344-f757-c86411073075 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 62032-504-00 | 2019-11-13 | C162847 | 48780-1 | 97449f38-cc9e-f6ea-e053-dbdaa90aa703 | 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% and Oxybenzone USP, 5.5%) Skin Bleaching Cream with Sunscreens |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62032-100-36 | NU-DERM STARTER SET NORMAL-DRYSKIN TRANSFORMATION SYSTEM | 57 g in 1 BOTTLE, PLASTIC | CREAM | 57 g | 40 mg in 1g | 1 |
| 62032-101-36 | NU-DERM STARTER SET NORMAL-DRYSKIN TRANSFORMATION SYSTEM | 57 g in 1 BOTTLE, PLASTIC | CREAM | 57 g | 40 mg in 1g | 1 |
| 62032-116-36 | NU-DERM STARTER SET NORMAL-DRYSKIN TRANSFORMATION SYSTEM | 57 g in 1 BOTTLE, PLASTIC | LOTION | 57 g | 40 mg in 1g | 1 |
| 62032-200-10 | NU-DERM STARTER SET NORMAL-DRYSKIN TRANSFORMATION SYSTEM | 30 mL in 1 BOTTLE, PLASTIC | CREAM | 30 mL | 90 mg in 1mL | 1 |
| 62032-504-00 | NU-DERM STARTER SET NORMAL-DRYSKIN TRANSFORMATION SYSTEM | 1 in 1 CARTON | KIT | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62032-100 | NU-DERM STARTER SET NORMAL-DRY SKIN TRANSFORMATION SYSTEM ( HYDROQUINONE, OCTINOXATE, OXYBENZONE AND ZINC OXIDE) KIT [OMP, INC.] | 1 | Current NDC, Legacy NDC | 20120521_f439d77f-ec5b-4534-a005-08f2e7af8d0c.zip |
| 62032-101 | NU-DERM STARTER SET NORMAL-DRY SKIN TRANSFORMATION SYSTEM ( HYDROQUINONE, OCTINOXATE, OXYBENZONE AND ZINC OXIDE) KIT [OMP, INC.] | 1 | Current NDC, Legacy NDC | 20120521_f439d77f-ec5b-4534-a005-08f2e7af8d0c.zip |
| 62032-116 | NU-DERM STARTER SET NORMAL-DRY SKIN TRANSFORMATION SYSTEM ( HYDROQUINONE, OCTINOXATE, OXYBENZONE AND ZINC OXIDE) KIT [OMP, INC.] | 1 | Current NDC, Legacy NDC | 20120521_f439d77f-ec5b-4534-a005-08f2e7af8d0c.zip |
| 62032-200 | NU-DERM STARTER SET NORMAL-DRY SKIN TRANSFORMATION SYSTEM ( HYDROQUINONE, OCTINOXATE, OXYBENZONE AND ZINC OXIDE) KIT [OMP, INC.] | 1 | Current NDC, Legacy NDC | 20120521_f439d77f-ec5b-4534-a005-08f2e7af8d0c.zip |
| 62032-504 | NU-DERM STARTER SET NORMAL-DRY SKIN TRANSFORMATION SYSTEM ( HYDROQUINONE, OCTINOXATE, OXYBENZONE AND ZINC OXIDE) KIT [OMP, INC.] | 1 | Legacy NDC, 5 package rows | 20120521_f439d77f-ec5b-4534-a005-08f2e7af8d0c.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| HYDROQUINONE | ACTIVE INGREDIENT | XV74C1N1AE | 1 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| HYDROQUINONE | ACTIVE MOIETY | XV74C1N1AE | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| C13-14 ISOPARAFFIN | INACTIVE INGREDIENT | E4F12ROE70 | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| DIETHANOLAMINE CETYL PHOSPHATE | INACTIVE INGREDIENT | 4UG0316V9S | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| ETHYLHEXYL STEARATE | INACTIVE INGREDIENT | EG3PA2K3K5 | 1 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| ISOBUTYLPARABEN | INACTIVE INGREDIENT | 0QQJ25X58G | 1 | |
| ISOPROPYL PALMITATE | INACTIVE INGREDIENT | 8CRQ2TH63M | 1 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | 1 | |
| LAURETH-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PHENYL TRIMETHICONE | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| PPG-2 MYRISTYL ETHER PROPIONATE | INACTIVE INGREDIENT | 88R97D8U8A | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 1 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| TROLAMINE SALICYLATE | INACTIVE INGREDIENT | H8O4040BHD | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 62032-504 | 62032-504-00 |
| 62032-100 | 62032-100-36 |
| 62032-101 | 62032-101-36 |
| 62032-200 | 62032-200-10 |
| 62032-116 | 62032-116-36 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | GEL / TOPICAL | 7 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SUSPENSION / ORAL | 8 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SOLUTION / TOPICAL | 0.04 %w/w | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | CREAM / TOPICAL | 1 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SOLUTION / ORAL | 14 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | CREAM / TOPICAL | 112 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CREAM / TOPICAL | 69 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | CREAM / TOPICAL | 0.4 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | LOTION / TOPICAL | 5 %w/w | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SUSPENSION / ORAL | 8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | CREAM / TOPICAL | 0.4 %w/w | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | LOTION / TOPICAL | 3627 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | LOTION / TOPICAL | 5 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CREAM / TOPICAL | 6 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | GRANULE, FOR SOLUTION / ORAL | 14 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CREAM / TOPICAL | 214 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SOLUTION / TOPICAL | 0.04 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SUSPENSION / ORAL | 8 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | CREAM / TOPICAL | 0.2 %w/w | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SOLUTION / ORAL | 14 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| LACTIC ACID | LACTIC ACID | 33X04XA5AT | LOTION / TOPICAL | 5.7 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | GRANULE, FOR SOLUTION / ORAL | 14 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | CREAM / TOPICAL | 112 mg | ||
| ISOPROPYL PALMITATE | ISOPROPYL PALMITATE | 8CRQ2TH63M | CREAM / TOPICAL | 112 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / TOPICAL | 14 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | SOLUTION / ORAL | 14 mg | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | GRANULE, FOR SOLUTION / ORAL | 14 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | GEL / TOPICAL | 7 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Adverse event summaries are temporarily unavailable. Other product information remains available.