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

  • 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 May 13, 2014

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  • SPF 30 Sunscreen Lotion

  • Active Ingredients

    Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0%, Titanium Dioxide 2.5%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging. This products 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

    f rash occurs.

  • Keep out of Reach of Children

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

  • 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 Ingredients

    Water, Cetearyl Alcohol, Xanthan Gum, C12-15 Alkyl Benzoate, Myristyl Propionate, Propylene Glycol, Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl Butylcarbamate, DMDM Hydantoin, Fragrance.

  • Other information

    Protect this product from excessive heat and direct sun

  • Questions or Comment ?

    Call toll free

  • Representative Label

    Sunscreen30ml

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 30 
    octinoxate, octisalate, oxybenzone, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31190-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.5 mg  in 1 mL
    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
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31190-210-2020 mL in 1 BOTTLE
    2NDC:31190-210-3030 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/13/2014
    Labeler - Shanghai Kejing Cleaning Products Co., Ltd (526877847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Kejing Cleaning Products Co., Ltd526877847manufacture(31190-210)
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