GLYTONE RETEXTURIZE BODY - octinoxate, octisalate, oxybenzone lotion 
Glytone

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 Body



Warnings

For external use only

When using this product

Stop use and ask a doctor if



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



Uses

Active Ingredients                                 Purpose

Octinoxate 7.5%                                       Sunscreen

Octisalate 5.0%                                         Sunscreen

Oxbenzone 3.0%                                       Sunscreen



Directions



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.

label


Glytone retexturize body lotion

SPF 15

Glycolic complex

250 ml e/ 8.4 fl. oz.

Purpose   sunscreen



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

GLYTONE RETEXTURIZE BODY 
octinoxate, octisalate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-208
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate18.75 mL  in 250 mL
octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate12.5 mL  in 250 mL
oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone7.5 mL  in 250 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-208-011 in 1 BOX
1250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/19/2010
Labeler - Glytone (117196928)

Revised: 2/2011
Document Id: fb08a86b-2bca-499c-b2ea-736192f29614
Set id: bf25db75-e3c0-4403-bb85-d418bc2ef4a1
Version: 2
Effective Time: 20110201
 
Glytone