SUNSCREEN WIPE KGP- homosalate octinoxate octisalate oxybenzone cloth

Sunscreen Wipe by

Drug Labeling and Warnings

Sunscreen Wipe by is a Otc medication manufactured, distributed, or labeled by KGP Products, Inc. (dba PREMIER), ITW Dymon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                                                                                          Purpose

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

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

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

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

PURPOSE

Uses

• Provides high protection against sunburn.
• Retains SPF after 80 minutes of sweating or activity in the water.
  

WHEN USING

Warnings

For external use only.

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

WHEN USING

When using this product

• Keep out of eyes.  Rinse with water to remove.
  

STOP USE

Stop use and ask a doctor

• If rash or irritation develops and lasts.
  

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.

WHEN USING

Directions

• Unfold towel.
• Apply evenly before sun exposure.
  
• For children under 6 months, consult a doctor.
• Reapply after towel drying, swimming or sweating.
  

QUESTIONS

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Ethanol, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN WIPE  KGP
homosalate octinoxate octisalate oxybenzone cloth

Product 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