OTC Medication Information: Sunscreen Wipe KGP

SUNSCREEN WIPE KGP- homosalate, octinoxate, octisalate and 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

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

Warnings

For external use only.

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

When using this product

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

Stop use and ask a doctor

  • If rash or irritation develops and lasts.

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

Directions

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

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Ethanol, Fragrance

Single pack
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (SALICYLIC ACID) HOMOSALATE 20 g in 856 mL
OCTINOXATE (2-ETHYLHEXYL 4-PHENYLBENZOPHENONE-2′-CARBOXYLATE) OCTINOXATE 75 g in 856 mL
OCTISALATE (SALICYLIC ACID) OCTISALATE 40 g in 856 mL
OXYBENZONE (BENZOPHENONE) OXYBENZONE 50 g in 856 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL 80.1 g in 856 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52648-6175-1 9 mL in 1 PACKET None
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 Operations
ITW Dymon 103307604 manufacture

Revised: 09/2010 KGP Products, Inc. (dba PREMIER)

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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