Label: SPORT SUNBLOCK- octinoxate and titanium dioxide lotion 

  • Label RSS
  • 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 02/13

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Octyl Methoxycinnamate 7%

    Titanium Dioxide 2.8%

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  • Purpose

    Sunscreen

    Sunscreen

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  • Use

    helps prevent sunburn

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  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash occurs

    Keep out of reach of children.

    If product is swallowed, get medical help or call a Poison Control Center right away.

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  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • children under 6 months: Ask a doctor
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  • Other information

    protect this product from excessive heat and direct sun

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  • Inactive Ingredients

    beeswax, carbomer, cetyl alcohol, dimethicone, disodium edta, fragrance, glycerin, glyceryl stearate se, glyceryl stearate and peg-100 stearate, methylparaben, propylene glycol, propylparaben, stearic acid, triethanolamine, water

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  • Package label

    Sport Sunscreenimage of sunscreen tube

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  • INGREDIENTS AND APPEARANCE
    SPORT SUNBLOCK 
    octinoxate and titanium dioxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67510-0083
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 7 g  in 100 mL
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.8 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX  
    CETYL ALCOHOL  
    DIMETHICONE  
    EDETATE DISODIUM  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    PEG-100 STEARATE  
    METHYLPARABEN  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    STEARIC ACID  
    TROLAMINE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67510-0083-5 100 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/27/2011
    Labeler - Kareway Product, Inc. (121840057)
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