Label: SPF 30 SUNSCREEN- zinc oxide, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2023

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  • ACTIVE INGREDIENT

    Zinc oxide 9%

    Titanium Dioxide 4.51%

  • PURPOSE

    Sunscreen

  • USES

    • helps prevent sunburn • If used as directed
    with other sun protection measutes decreases the
    risk of skin cancer and early skin aging caused by the sun

  • WARNINGS

    • 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 doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact
    a Poison Control Center right away.

  • DIRECTIONS

    Apply liberally 15 minutes before
    sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying• at least every 2 hours • Children under 6 months of age: ask a doctor • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early
    skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2pm • wear long-sleeved shirts, pants, hats and sunglasses.

  • INACTIVE INGREDIENTS

    Water, Caprylic / Capric Triglyceride, Cetearyl Alcohol, STEARETH-2, Glycerin, STEARETH-21, Aloe Vera, Dimethicone, Phenoxyethanol, Sodium Stearoyl Glutamate, Xanthan Gum, Disodium EDTA, Ethylhexylglycerin

  • STORAGE AND HANDLING

    protect the product in this container from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    SPF 30 SUNSCREEN 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83294-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.51 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    STEARETH-21 (UNII: 53J3F32P58)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    STEARETH-2 (UNII: V56DFE46J5)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83294-101-18118 mL in 1 TUBE; Type 0: Not a Combination Product08/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/22/2022
    Labeler - CLEURE (116355659)
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