Label: SPF 30 SUNSCREEN - octinoxate, oxybenzone and octisalate lotion

  • NDC Code(s): 76138-203-09
  • Packager: INNOVATION SPECIALTIES
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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  • ACTIVE INGREDIENT

    Active Ingredients

    Octinoxate 7.5 %

    Oxybenzone 4.0 %

    Octisalate 1.0 %

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  • PURPOSE

    Purpose

    Sunscreen

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS & USAGE

    Directions

    Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, Swimming or perspiring.

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  • WARNINGS

    Warnings:

    For external use only.

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  • DOSAGE & ADMINISTRATION

    Dosage and Administration

    Apply liberally 15-20 minutes before sun exposure. Reapply as needed or after towel drying, Swimming or perspiring.

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Mineral Oil, Stearic Acid, Cetearyl Alcohol (and) Polysorbate 60, Cetyl Alcohol, Glyceryl Stearate SE, Sodium Lauryl Sulfate, Triethanolamine, Diazolidinyl Urea, Dimethicone, Carbomer, Methyl Paraben, Proplyparaben.

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  • INGREDIENTS AND APPEARANCE
    SPF 30 SUNSCREEN 
    octinoxate, oxybenzone, octisalate lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76138-203
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 mL
    OXYBENZONE (OXYBENZONE) OXYBENZONE 4 g  in 100 mL
    OCTISALATE (OCTISALATE) OCTISALATE 1 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    MINERAL OIL  
    STEARIC ACID  
    CETOSTEARYL ALCOHOL  
    POLYSORBATE 60  
    CETYL ALCOHOL  
    GLYCERYL STEARATE SE  
    SODIUM LAURYL SULFATE  
    TROLAMINE  
    DIAZOLIDINYL UREA  
    DIMETHICONE  
    CARBOMER COPOLYMER TYPE A  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76138-203-09 65 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/01/2012
    Labeler - INNOVATION SPECIALTIES (030837314)
    Establishment
    Name Address ID/FEI Business Operations
    CORETEX PRODUCTS INC 061944620 manufacture(76138-203)
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