Label: SUNSCREEN - octinoxate and oxybenzone lipstick

  • 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 02/14

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  • ACTIVE INGREDIENT

    Octinoxate (7.5%)

    Oxybenzone (4%)

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  • PURPOSE

    Sunscreen

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  • INDICATIONS & USAGE

    Helps prevent sunburn and chapped lips

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  • INACTIVE INGREDIENT

    Petrolatum, Octyl Palmitate, Beeswax, Paraffin, Mineral Oil, Ceresin, Cetyl Alcohol, Fragrance, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate (Vitamin E), Propylparaben

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  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    octinoxate, oxybenzone lipstick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:19392-300
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg  in 1 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 40 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM  
    ETHYLHEXYL PALMITATE  
    YELLOW WAX  
    PARAFFIN  
    MINERAL OIL  
    CERESIN  
    CETYL ALCOHOL  
    ALOE VERA LEAF  
    .ALPHA.-TOCOPHEROL ACETATE  
    PROPYLPARABEN  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor TROPICAL FRUIT PUNCH (tropical flavor) , SPEARMINT (spearmint flavor) , BUBBLE GUM (bubble gum flavor) , VANILLA (vanilla flavor) , CHERRY (cherry flavor) , STRAWBERRY (strawberry flavor) , BERRY (berry flavor) , WATERMELON (watermelon flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:19392-300-01 4 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/01/2010
    Labeler - Humphreyline (122539042)
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