SUNSCREEN WIPE KGP- homosalate octinoxate octisalate oxybenzone  cloth 
KGP Products, Inc. (dba PREMIER)

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.

----------

Active Ingredient                                                                                                          Purpose

Homosalate (2%)..........................................................................................................Sunscreen

Octinoxate (7.5%).........................................................................................................Sunscreen

Octisalate (4%).............................................................................................................Sunscreen

Oxybenzone (5%)........................................................................................................Sunscreen

Uses

Warnings

For external use only.

Flammable.  Keep away from heat and flame when applying this product.

When using this product

Stop use and ask a doctor

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

Directions

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Ethanol, Fragrance

Single pack

SUNSCREEN WIPE  KGP
homosalate octinoxate octisalate oxybenzone cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52648-6175
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (SALICYLIC ACID - UNII:O414PZ4LPZ) HOMOSALATE20 g  in 856 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (2-ETHYLHEXYL 4-PHENYLBENZOPHENONE-2'-CARBOXYLATE - UNII:93NOD9WBCS) OCTINOXATE75 g  in 856 mL
OCTISALATE (UNII: 4X49Y0596W) (SALICYLIC ACID - UNII:O414PZ4LPZ) OCTISALATE40 g  in 856 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (BENZOPHENONE - UNII:701M4TTV9O) OXYBENZONE50 g  in 856 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M) 80.1 g  in 856 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52648-6175-19 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/28/2010
Labeler - KGP Products, Inc. (dba PREMIER) (004173662)
Registrant - ITW Dymon (103307604)
Establishment
NameAddressID/FEIBusiness Operations
ITW Dymon103307604manufacture

Revised: 9/2010
Document Id: 556865f0-7dda-46b4-9948-d987b95f740f
Set id: c649a9be-5e7a-4436-aea1-017e36b07d08
Version: 2
Effective Time: 20100930
 
KGP Products, Inc. (dba PREMIER)