Label: SPF 30 SUNSCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide spray

  • NDC Code(s): 31190-330-01, 31190-330-02
  • Packager: Shanghai Kejing Cleaning Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 July 17, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredients

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

    Titanium Dioxide 2.5%

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  • PURPOSE

    Purpose

    Sunscreen

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  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn

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  • 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.

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  • 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.

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  • 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.

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  • 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

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  • STORAGE AND HANDLING

    Other information

    Protect this product from excessive heat and direct sun

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  • QUESTIONS

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

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  • SPL UNCLASSIFIED SECTION

    Insect repellent active ingredients: soybean oil  3%

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  • INGREDIENTS AND APPEARANCE
    SPF 30 SUNSCREEN 
    octinoxate, octisalate, oxybenzone, titanium dioxide spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:31190-330
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 g
    SOYBEAN OIL (UNII: 241ATL177A) (SOYBEAN OIL - UNII:241ATL177A) SOYBEAN OIL 3.0 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.0 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4.0 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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     
    Shape Size
    Flavor VANILLA Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:31190-330-01 30 g in 1 BOTTLE; Type 0: Not a Combination Product 06/25/2016
    2 NDC:31190-330-02 60 g in 1 PACKAGE; Type 0: Not a Combination Product 06/25/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 06/25/2016
    Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Establishment
    Name Address ID/FEI Business Operations
    Shanghai Kejing Cleaning Products Co., Ltd. 526877847 manufacture(31190-330)
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