Label: - octinoxate, octisalate, oxybenzone, titanium dioxide spray

  • 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.

Drug Label Information

Updated June 25, 2016

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  • ACTIVE INGREDIENT

    Active Ingredients

    Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%,

    Titanium Dioxide 2.5%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn

  • WARNINGS

    WARNINGS:

    Skin Cancer/Skin Aging Alert: Spending time in the sun

    increase your risk of skin cancer and early skin aging.

    this product had been shown only to prevent sunburn,

    not skin cancer or 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

    Keep out of reach of children. If product swallowed, get

    medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply generously & evenly before sun exposure. Reapply as

    needed or after towel drying, swimming or sweating.

    Ask doctor before using on children under 6 months.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Cetearyl Alcohol, Xanthan Gum,

    C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol,

    Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl

    Butylcarbamate, DMDM Hydantoin, Fragrance

  • STORAGE AND HANDLING

    Other information

    Protect this product from excessive heat and direct sun

  • QUESTIONS

    Questions or Comment? Call toll free 1-877-254-2281

  • SPL UNCLASSIFIED SECTION

    Insect repellent active ingredients: soybean oil  3%

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
     
    octinoxate, octisalate, oxybenzone, titanium dioxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31190-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A) SOYBEAN OIL3.0 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.0 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4.0 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MYRISTYL PROPIONATE (UNII: P59053E7NJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31190-230-0130 g in 1 BOTTLE; Type 0: Not a Combination Product06/25/2016
    2NDC:31190-230-0260 g in 1 PACKAGE; Type 0: Not a Combination Product06/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/25/2016
    Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Kejing Cleaning Products Co., Ltd.526877847manufacture(31190-230)
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