Label: SPORT SUNBLOCK- octinoxate and titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL

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.

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Updated October 4, 2019

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  • Active Ingredients

    Octyl Methoxycinnamate 7%

    Titanium Dioxide 2.8%

  • Purpose

    Sunscreen

    Sunscreen

  • Use

    helps prevent sunburn

  • 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.

  • 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
  • Other information

    protect this product from excessive heat and direct sun

  • Inactive Ingredients

    Water, Glycerin, Stearic acid,

    Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate,

    Phenoxyethanol, Triethanolamine, Dimethicone, Acrylates/

    C10-30 alkyl acrylate crosspolymer, Chlorphenesin,

    Lavandula Angustifolia (Lavender) Extract, Salvia Sclarea

    (Clary) Extract, Hyacinthus Orientalis Extract, Chamomilla

    Recutita (Matricaria) Flower/Leaf Extract, Borago officinalis

    Extract, Centaurea cyanus flower Extract, Butylene Glycol,

    1,2- Hexanediol, Ethylhexylglycerin, Disodium EDTA, Fragrance

  • Package label

    Sport Sunscreen

    tube

  • INGREDIENTS AND APPEARANCE
    SPORT SUNBLOCK 
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0083
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0083-5100 mL in 1 TUBE; Type 0: Not a Combination Product10/27/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/27/2011
    Labeler - Kareway Product, Inc. (121840057)
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