GLYTONE RETEXTURIZE HAND - octinoxate, octisalate and oxybenzone cream
Genesis Pharmaceuticals

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 Purpose

Octinoxate 6.0% Sunscreen

Octisalate 3.0% Sunscreen

Oxybenzone 5.0% Sunscreen

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.

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.

label

Glytone Body

retexturize hand cream SPF 15

glycolic complex

120 mL E/4 Fl. Oz.

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	7.2 mm in 120 mL
Octisalate (Octisalate)	Octisalate	3.6 mL in 120 mL
Oxybenzone (Oxybenzone)	Oxybenzone	6 mL in 120 mL

#	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

Labeler - Genesis Pharmaceuticals (117196928)

Revised: 5/2010

Document Id: ea5e12de-b730-4e87-bfd3-b3fef3547c54

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

Version: 1

Effective Time: 20100524

Genesis Pharmaceuticals