GLYTONE RETEXTURIZE BODY- octinoxate, octisalate, oxybenzone lotion

glytone retexturize body by

Drug Labeling and Warnings

glytone retexturize body by is a Otc medication manufactured, distributed, or labeled by Glytone. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

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.
  

INACTIVE INGREDIENT

Inactive Ingredients Water (aqua), Glycolic Acid, C12-15 Alkyl Benzoate, Cyclomethicone, Glyceryl Stearate, Glycerin, Ammonium Hydroxide, PEG-150 Stearate, Polyacrylamide, Cetyl Alcohol, Cetearyl Alcohol, Butyrospermum Parkii (Shea Butter), Cholesterol, Phenozyethanol, Dimethiconol, C13-14 Isoparafin, Methylparaben, Xanthan gum, cetearyl glucoside, disodium EDTA, tocopheryl acetate, laureth-7

INDICATIONS & USAGE

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection
• Provides moderate protection against sunburn.
  

ACTIVE INGREDIENT

Active Ingredients                                 Purpose

Octinoxate 7.5%                                       Sunscreen

Octisalate 5.0%                                         Sunscreen

Oxbenzone 3.0%                                       Sunscreen

DOSAGE & ADMINISTRATION

Directions

• Apply daily to cleansed body skin or as directed by your physician; avoid face
• Apply generously before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
  

INFORMATION FOR PATIENTS

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and harmful effects of the sun. This product is ot intended for sunbathing.

PRINCIPAL DISPLAY PANEL

Glytone retexturize body lotion

SPF 15

Glycolic complex

250 ml e/ 8.4 fl. oz.

PURPOSE

Purpose   sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INGREDIENTS AND APPEARANCE

GLYTONE RETEXTURIZE BODY 
octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-208
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51)	octinoxate	18.75 mL  in 250 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W)	octisalate	12.5 mL  in 250 mL
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y)	oxybenzone	7.5 mL  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCOLIC ACID (UNII: 0WT12SX38S)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIA (UNII: 5138Q19F1X)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SHEA BUTTER (UNII: K49155WL9Y)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
METHYLPARABEN (UNII: A2I8C7HI9T)
XANTHAN GUM (UNII: TTV12P4NEE)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
LAURETH-7 (UNII: Z95S6G8201)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-208-01	1 in 1 BOX
1		250 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/19/2010

Labeler - Glytone (117196928)