Label: GLYTONE RETEXTURIZE BODY- octinoxate, octisalate, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 64760-208-01 - Packager: Glytone
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 1, 2011
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- WARNINGS
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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
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INFORMATION FOR PATIENTS
- PRINCIPAL DISPLAY PANEL
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INGREDIENTS AND APPEARANCE
GLYTONE RETEXTURIZE BODY
octinoxate, octisalate, oxybenzone lotionProduct 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)