Obagi Nu-Derm Sunfader

OBAGI NU-DERM SUNFADER — hydroquinone, octinoxate and oxybenzone cream
YS PLUS CORPORATION

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx Only

For external use only

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 C6H6)2;

molecular weight is 110.11 g / moL.

Each gram of Obagi Nu — Derm 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 ESTA, methylparaben, BHT,

propylparaben, saponins, butylparaben

Each gram of Obagi Nu 0 Derm Blender contains:

Active ingredient: Hydroquinone USP 4 % (40 mg / g)

Inactive ingredients: water, glycerin, cetyl alcohol, PPG — 2 myristal ether propionate, sodium

lauryl sulfate, TEA — salicylate, lactic acid, phenyl trimethicone, tocopherylcetate, sodium metabisulfite, ascorbic acid, methylparaben, disodium EDTA,

propylparaben, saponins, BHT

Each gram of Obagi Nu — Derm Sunfader contains:

Active ingredients: Hydroquinone USP 4 % (40 ,g /g/); Octinoxate USP, 7.5 %; Oxybenzene USP.

5.5 %

Inactive ingredients: water, cetyl alcohol, glycerin, sodium lauryl sulfate, stearyl alcohol,

tocopheryl acetate, ascorbic acid, sodium metabisulfite, disodium EDTA, BHT, saponins, propylparaben, 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 ultraiolet light

will cause repigmentation of the bleached areas, which may be orevented by the use of

sunblocking agents or sunscreen agents contained in the Obagi Nu — Derm Sunfader and Obagi

Nu — Derm Sun shield Matte Broad Spectrum SPF 50.

For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma,

freckles, senile pentigines, and other unwanted areas of melanin hyperpigmentation

People with prior history of sensitivity or allergic reaction to this product or any of its

ingredients should not use it. The safety of 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 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 metabusulfite, a sulfite that may cause allergic — type reactions including

anaphylactic symptoms and life — threatening or elss severe asthmatic episodes in

certain susceptible people. The overall prevalence of sulfite sensitivity in te general population is

unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in

nonasthmatic people

(See also 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.

No systemic adverse reactions ahve been reported. Occasional hypersensitivity

(localized contact dermatitis) may occur, in which case the product should be

discontinues and the physician notified immediately.

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.

Store at controlled room temperature: 15 C — 25 C (59 F — 77 F). Keep out of direct sunlight.

copy of label
(click image for full-size original)

OBAGI NU-DERM SUNFADER hydroquinone, octinoxate, oxybenzone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69269-116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 55 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLPARABEN
STEARYL ALCOHOL
SODIUM LAURYL SULFATE
CETYL ALCOHOL
GLYCERIN
ASCORBIC ACID
.ALPHA.-TOCOPHEROL ACETATE
EDETATE DISODIUM
SODIUM METABISULFITE
WATER
METHYLPARABEN
PROPYLPARABEN
BUTYLATED HYDROXYTOLUENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69269-116-36 57 g in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2014
Labeler — YS PLUS CORPORATION (843007597)
Establishment
Name Address ID/FEI Operations
YS PLUS CORPORATION 843007597 repack (69269-116)

Revised: 10/2014 YS PLUS CORPORATION

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