Label: SUNSCREEN WIPE KGP- homosalate octinoxate octisalate oxybenzone cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 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

    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

    Single pack

  • INGREDIENTS AND APPEARANCE
    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
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