Label: SUNSCREEN WIPE KGP- homosalate octinoxate octisalate oxybenzone cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 52648-6175-1 - Packager: KGP Products, Inc. (dba PREMIER)
- Category: HUMAN OTC DRUG LABEL
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 September 30, 2010
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ACTIVE INGREDIENT
Active Ingredient Purpose
Homosalate (2%)..........................................................................................................Sunscreen
Octinoxate (7.5%).........................................................................................................Sunscreen
Octisalate (4%).............................................................................................................Sunscreen
Oxybenzone (5%)........................................................................................................Sunscreen
- PURPOSE
- WHEN USING
- WHEN USING
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- KEEP OUT OF REACH OF CHILDREN
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INGREDIENTS AND APPEARANCE
SUNSCREEN WIPE KGP
homosalate octinoxate octisalate oxybenzone clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52648-6175 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (SALICYLIC ACID - UNII:O414PZ4LPZ) HOMOSALATE 20 g in 856 mL OCTINOXATE (UNII: 4Y5P7MUD51) (2-ETHYLHEXYL 4-PHENYLBENZOPHENONE-2'-CARBOXYLATE - UNII:93NOD9WBCS) OCTINOXATE 75 g in 856 mL OCTISALATE (UNII: 4X49Y0596W) (SALICYLIC ACID - UNII:O414PZ4LPZ) OCTISALATE 40 g in 856 mL OXYBENZONE (UNII: 95OOS7VE0Y) (BENZOPHENONE - UNII:701M4TTV9O) OXYBENZONE 50 g in 856 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 80.1 g in 856 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52648-6175-1 9 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/28/2010 Labeler - KGP Products, Inc. (dba PREMIER) (004173662) Registrant - ITW Dymon (103307604) Establishment Name Address ID/FEI Business Operations ITW Dymon 103307604 manufacture