Indications and uses
Glytone SunVanish is indicated for the gradual lightening of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
Glytone SunVanish Skin Lightening
- Manufacturer
- Pierre Fabre USA Inc.
- Effective date
- 2020-05-18
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:24:43
Label at a glance#
ProductGlytone SunVanish Skin Lightening
Active ingredientHYDROQUINONE, AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Label structure12 sections
Dosage and administration
Glytone SunVanish should be applied daily in the morning to affected areas and rubbed in well, or as directed by a physician. If no lightening effect is seen after 2 months of treatment, use of this product should be discontinued. Limit sunlight exposure during the day by applying an effective broad spectrum sunscreen (SPF 15 or higher) or by wearing sun-protective clothing to cover treated areas.
Contacts and useful links#
Websitewww.glytone.com
www.glytone.com
www.glytone.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Glytone SunVanish
HYDROQUINONE USP, 4%
Skin Lightening Cream
with Broad Spectrum SPF 25
Rx Only
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
I. DESCRIPTION
Each gram of Glytone SunVanish (Hydroquinone USP, 4%) Skin Lightening Cream with Broad Spectrum SPF 25 contains 40 mg of Hydroquinone USP with 20 mg of Avobenzone, 75 mg of Octinoxate, 18.6 mg of Octocrylene, and 50 mg Oxybenzone in a cream base of Cetearyl Alcohol, Glycerin, Edetate Disodium, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Lauryl Sulfate, Sodium Metabisulfite, and Sorbic Acid. The chemical name for hydroquinone is: 1,4-benzenediol. The molecular formula is C 6H 6O 2 and molecular weight is 110.11. Hydroquinone has the following structural formula:
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
Glytone SunVanish is indicated for the gradual lightening 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
SPL UNCLASSIFIED SECTION
A. 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.
SPL UNCLASSIFIED SECTION
B. May produce exogenous ochronosis, a gradual blue-black darkening of the skin, the occurrence of which should prompt discontinuation of treatment.
SPL UNCLASSIFIED SECTION
C. Sunscreen use is an essential aspect of hydroquinone therapy because minimal sunlight sustains melanocytic activity. The sunscreen agents in Glytone SunVanish provide sun protection during skin lightening therapy. During the day, supplement therapy by using an effective broad spectrum sunscreen and avoiding unnecessary sun exposure, or wear sun-protective clothing to cover treated areas in order to prevent repigmentation from occurring.
VI. PRECAUTIONS
See WARNINGS
PREGNANCY SECTION
A. Test for skin sensitivity before using Glytone 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.
Hydroquinone is a skin lightening 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.
NURSING MOTHERS SECTION
B. Avoid contact with eyes, nose, mouth, and lips. In case of accidental contact, patient should rinse thoroughly with warm water and contact a physician.
PEDIATRIC USE SECTION
C. 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.
SPL UNCLASSIFIED SECTION
D. 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 on pregnant women.
SPL UNCLASSIFIED SECTION
E. 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.
SPL UNCLASSIFIED SECTION
F. 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 metabisulfite is a potential. See WARNINGS.
VIII. OVERDOSAGE
There have been no systemic reactions from the use of topical hydroquinone. 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
Glytone SunVanish should be applied daily in the morning to affected areas and rubbed in well, or as directed by a physician. If no lightening effect is seen after 2 months of treatment, use of this product should be discontinued.
Limit sunlight exposure during the day by applying an effective broad spectrum sunscreen (SPF 15 or higher) or by wearing sun-protective clothing to cover treated areas.
X. HOW SUPPLIED
SunVanish is available as follows:
SizeNDC Number
Net Wt. 2 Oz. / 56 g tube 64760-702-01
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:
Pierre Fabre USA, Inc.
Parsippany, NJ 07054
Made in U.S.A.
1-800-GLYTONE (459-8663)
Rev. 121118
PRINCIPAL DISPLAY - GLYTONE SunVanish Carton 56 g
NDC 64760-702-01
GLYTONE
SunVanish
Skin Lightening
Cream
Broad Spectrum Sunscreen SPF 25
BRIGHTENING
4% Hydroquinone, USP
Rx Only
NET WT. 56.7 g / 2 OZ.
Products#
Every source-derived product name is available through these pages.
- Glytone SunVanish Skin Lightening
- Hydroquinone
- CETOSTEARYL ALCOHOL
- GLYCERIN
- EDETATE DISODIUM
- ISOPROPYL PALMITATE
- PROPYLENE GLYCOL
- WATER
- SODIUM LAURYL SULFATE
- SODIUM METABISULFITE
- SORBIC ACID
- AVOBENZONE
- OCTINOXATE
- OCTOCRYLENE
- OXYBENZONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64760-702 | 64760-702-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| ISOPROPYL PALMITATE | 8CRQ2TH63M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SODIUM METABISULFITE | 4VON5FNS3C | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| HYDROQUINONE | XV74C1N1AE | ACTIB |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
Source Document#
openFDA label cross-check#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a5f17279-5e4f-8c28-e053-2a95a90a6691 | 9b3d564a-de28-4a92-87f0-0ea750e3bfa5 | 2020-05-18 | Warnings, Adverse reactions | a5f17279-5e4f-8c28-e053-2a95a90a6691 9b3d564a-de28-4a92-87f0-0ea750e3bfa5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.