Medication Guide App

Glytone Clarifying Cream

Generic Name: hydroquinone
Dosage Form: cream

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Glytone Clarifying Skin Bleaching



Active Ingredients

Octinoxate 7.5%

Oxybenzone 5.00%

Hydroquinone 4.00%

Avobenzone 2.00%

Octocrylene 1.86%



Purpose

Sunscreen

Skin bleaching

Sunscreen



Keep out of reach of children



Uses

Skin bleaching. Lightens dark (brownish) discoloration/pigment, spots, blotches and areas including freckles, age and liver spots and pigment in the skin that may occur in pregnancy or from the use of oral contraceptives.

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early aging caused by the sun.



Warnings

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove

Stop  use and ask a doctor if rash occurs

If pregnant or breast-feeding, ask a health professional before use

For external use only

Do not swallow. If swallowed, get  medical help or contact Poison Control right away

Keep out of reach of children

Do not use on children under 12 years of age


Directions

Apply once daily to area where lightening is desired or as directed by physician

Apply liberally 15 minutes before sun exposure

Reapply every 2 hours

Apply to all areas exposed to the sun

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures, including: Limit time in the sun, especially from 10 am - 2 pm., wear long sleeve shirts,pants, hats and sunglasses.



Inactive Ingredients

Water (Aqua), Propylene glycol, Cetearyl alcohol, Glycerin, sodium lauryl sulfate, isopropyl palmitate, sodium metabisulfite, sorbic acid, disodium EDTA



Other Information

This product is not intended as a sunscreen for sunbathing use

Store this product at controlled room temperature 15-30 C (59-86 F)

Keep this product away from heat (above 30 C/86 F) and direct sunlight



Glytone Clarifying skin bleaching

sunvanish

broad spectrum

sunscreen SPF25

water resistant (80 minutes)

RX only

4.0 hydroquinone

Net wt. 2 oz/56 g

Glytone sunvanish is formulated to help lighten dark (brownish) discolorations such as freckles, age and liver spots or pigment in the skin that may occur during pregnancy, from the use of oral contraceptives or as a result of age or sun damage.

It contains 4% hydroquinone, a skin lightening agent that prevents the overproduction of melanin and increases the breakdown of melanosomes. Glycerin provides hydration for smoother skin and sunscreen actives offer broad spectrum protection from UVA/UVB rays.

Glytone sunvanish provides an efficient solution to address hyperpigmentation on a daily basis. It helps to brighten skin tone and clarify for a more even complexion.

Directions: Apply once daily to area where lightening is desired or as directed by a physician.

Warnings: 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.

This product is not intended as a sunscreen for sunbathing use. See Drug Facts panel and package insert for full information.



GLYTONE CLARIFYING 
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
OCTINOXATE (OCTINOXATE) OCTINOXATE 4.2 g  in 56 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 2.8 h  in 56 g
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 2.24 g  in 56 g
AVOBENZONE (AVOBENZONE) AVOBENZONE 1.12 g  in 56 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 1.04 g  in 56 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 56 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 06/13/2012
Labeler - Genesis Pharmaceutical (784338563)
Establishment
Name Address ID/FEI Operations
Genesis Pharmaceutical 784338563 manufacture
Revised: 06/2012
 
Genesis Pharmaceutical



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