SUNSCREEN WIPE KGP (HOMOSALATE OCTINOXATE OCTISALATE OXYBENZONE ) CLOTH [KGP PRODUCTS, INC. (DBA PREMIER)]

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  • SUNSCREEN WIPE KGP (HOMOSALATE OCTINOXATE OCTISALATE OXYBENZONE ) CLOTH [KGP PRODUCTS, INC. (DBA PREMIER)]

SUNSCREEN WIPE KGP (HOMOSALATE OCTINOXATE OCTISALATE OXYBENZONE ) CLOTH [KGP PRODUCTS, INC. (DBA PREMIER)]
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NDC 52648-6175-1
Set ID c649a9be-5e7a-4436-aea1-017e36b07d08
Category HUMAN OTC DRUG LABEL
Packager KGP Products, Inc. (dba PREMIER)
Generic Name
Product Class
Product Number
Application Number PART352
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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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