Skip to Content
Diagnosed with psoriatic arthritis? Learn about biologics >>

Glytone Clarifying SunVanish

Generic Name: hydroquinone
Dosage Form: cream

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.

Glytone Clarifying SunVanish with Sunscreen

Skin Bleaching SunVanish

with sunscreen

HYDROQUINONE USP, 4%

RX only

FOR EXTERNAL USE ONLY

I. DESCRIPTION

Each 1 gram dose of SunVanish contains 40 mg of Hydroquinone USP, 75 mg of Octinoxate, 50 mg of Oxybenzone, 20 mg of Avobenzone, and 18.6 mg of Octocrylene in a cream base of Purified Water, Propylene Glycol, Cetearyl Alcohol, Glycerin, Sodium Lauryl Sulfate, Isopropyl Palmitate, Sodium Metabisulfite, Sorbic Acid, and Disodium EDTA.

II. 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 which may be prevented by the broad spectrum sunscreen agents contained in SunVanish.

III. INDICATIONS AND USAGE

SunVanish is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.

IV. CONTRAINDICATIONS

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.

V.  WARNINGS

A. CAUTION: 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.

B. Test for skin sensitivity before using SunVanish 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 warm water and contact their physician. If no bleaching or lightening effect is noted after 2 months of treatment, SunVanish should be discontinued. SunVanish is formulated for use as a skin bleaching agent and should not be used for the prevention of sunburn.

C. Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight exposure sustains melanocytic activity. The sunscreens in SunVanish provide the necessary sun protection during skin bleaching therapy. After clearing and during maintenance therapy, sun exposure should be avoided on bleached skin by application of a broad spectrum sunscreen greater than SPF 15 and protective clothing to prevent repigmentation.

D. Keep this and all medication out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

E. WARNING: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. 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.

VI. PRECAUTIONS

 SEE WARNINGS

A. 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 not be used in pregnant women.

B. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. This product is not recommended for use by nursing mothers.

C. Pediatric usage. Safety and effectiveness in children below the age of 12 years have not been established. Do not use on children under 12 years of age.

VII. ADVERSE REACTIONS

No systemic adverse reactions to hydroquinone have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately. Sensitivity to sodium metabisulfate is a potential. See WARNINGS.

VIII. OVERDOSAGE

There have been no systemic reactions from the use of topical hydroquinone in SunVanish in recommended quantities. However, 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, but indicates caution is warranted.

IX. DRUG DOSAGE AND ADMINISTRATION

SunVanish should be applied in the morning to the affected area and rubbed in well or as directed by your physician to achieve maximum therapeutic potential.

X. HOW SUPPLIED

SunVanish is available as follows:

Size                                                  NDC Number

Net Wt. 2 Oz. / 56 g tube                 64760-401-02

SunVanish should be stored at controlled room temperature 15° - 30° C (59° - 86° F). Do not expose to heat above 86° F or direct sunlight. 

  

Distributed by:

Genesis Pharmaceutical, Inc.

Parsippany, NJ 07054

Made in U.S.A.

1-800-GLYTONE (459-8663)

www.glytone-usa.com

Rev. 062413

 

PRINCIPAL DISPLAY - Sunvanish Carton 56 g

NDC 64760-401-02

GLYTONE CLARIFYING

Rx ONLY

skin beaching

sunvanish

with Broad Spectrum Sunscreen SPF 25

HYDROQUINONE, USP 4%

NET WT. 56 g / 2 OZ.

Glytone Clarifying SunVanish WITH SUNSCREEN 
hydroquinone cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64760-401
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 50 mg  in 1 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg  in 1 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 18.6 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
PROPYLENE GLYCOL  
CETOSTEARYL ALCOHOL  
GLYCERIN  
SODIUM LAURYL SULFATE  
ISOPROPYL PALMITATE  
SODIUM METABISULFITE  
SORBIC ACID  
EDETATE DISODIUM  
Packaging
# Item Code Package Description
1 NDC:64760-401-02 1 TUBE in 1 CARTON
1 56 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/13/2012
Labeler - Genesis Pharmaceutical, Inc. (117196928)
Revised: 08/2014
 
Genesis Pharmaceutical, Inc.



Hide