Label: SPF30 SUNSCREEN- octisalate, octisalate, oxybenzone 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 November 6, 2017

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  • Drug Facts

  • Active Ingredients:

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

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • WARNINGS:

    Skin Cancer/ Sking 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 and 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 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 1-888-543-0938

  • Distributed By:

    Event Blossom - Tustin, CA 92780 Made in China

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SPF30 SUNSCREEN 
    octisalate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71642-016
    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 DIOXIDE25 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 ANHYDROUS (UNII: 8NLQ36F6MM)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71642-016-0030 mL in 1 BOTTLE; Type 0: Not a Combination Product11/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/06/2017
    Labeler - Shanghai Mengna Personal Care Co., Ltd (526931632)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Mengna Personal Care Co., Ltd526931632manufacture(71642-016)
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