GLYTONE RETEXTURIZE HAND- octinoxate, octisalate and oxybenzone cream
Genesis Pharmaceutical, Inc.

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.

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Glytone retexturize hand

Active Ingredients

Octinoxate 6.0%

Octisalate 3.0%

Oxybenzone 5.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Higher SPF gives more sunburn protection

Porvides moderate protection against sunburn

Warnings

For external use only

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

This product is not intended for sunbathing.

Directions

Apply once or twice a day or as directed by your doctor; avoid face.

Apply generously before sun exposure and as needed.

Children under 6 months of age: ask a doctor.

Inactive Ingredients

Water (Aqua), Glycolic Acid, Cyclomethicone, Glyceryl Stearate, Polyacrylamide, Boron Nitride, Butylene Glycol, Ethylhexly Palmitate, Persea Gratissima (Avocado) Oil Unsaponifiables, Ammoniium Hydroxide, C13-14 Isoparaffin, Stearly Alcohol, Dimethiconol, Laureth-7, Magnesium Nitrate, Disodium EDTA, Tocopheryl Acetate, Methyl-chloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

Principal Display Panel

Glytone Body

retexturize hand cream SPF 15

glycolic complex

120 mL E/4 Fl. Oz

label .

GLYTONE RETEXTURIZE HAND
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:64760-207
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	60 mg in 1 mL
OCTISALATE (OCTISALATE)	OCTISALATE	30 mg in 1 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
GLYCOLIC ACID
CYCLOMETHICONE
GLYCERYL MONOSTEARATE
POLYACRYLAMIDE (10000 MW)
BORON NITRIDE
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
AVOCADO OIL UNSAPONIFIABLES
AMMONIA
C13-14 ISOPARAFFIN
STEARYL ALCOHOL
DIMETHICONOL (40 CST)
LAURETH-7
MAGNESIUM NITRATE
EDETATE DISODIUM
.ALPHA.-TOCOPHEROL ACETATE
METHYLCHLOROISOTHIAZOLINONE
MAGNESIUM CHLORIDE
METHYLISOTHIAZOLINONE

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64760-207-01	120 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/24/2010	08/31/2012

Labeler - Genesis Pharmaceutical, Inc. (117196928)

Revised: 8/2014

Document Id: 761b7bb0-8c22-4d12-8344-dc81f1ddd2d3

Set id: c38c82bc-6aed-4ea8-b593-43740c825e75

Version: 3

Effective Time: 20140808

Genesis Pharmaceutical, Inc.