Label: WARRIOR BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide lotion

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

Drug Label Information

Updated May 2, 2024

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  • Active Ingredients

    Titanium Dioxide 4.5%

    Zinc Oxide 4%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), 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 a doctor

    if rash occurs

    Keep out of reach of children

    If product is swallowed, get medical help or contact 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 two hours
      • 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 am - 2 pm
      • wear long-sleeve shirts, pants, hats and sunglasses
      • children under 6 months: ask a doctor
  • Inactive Ingredients

    Acrylic Acid/VP Crosspolymer, Allantoin, Aluminum Hydroxide, C12-15 Alkyl Benzoate, C13-15 Alkane, Camellia Oleifera (Green Tea) Leaf Extract, Caprylyl Glycol, Ceteareth-20, Cetyl Alcohol, Glycerin, Isododecane, Isohexadecane, Phenoxyethanol, Polyglyceryl-3 Distearate, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, VP/Acrylates/Lauryl Methacrylate Copolymer, Water

  • Other Information

    protect this product from excessive heat and direct sun

  • Warrior Broad Spectrum SPF 50 Mineral Sunscreen Lotion

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    WARRIOR  BROAD SPECTRUM SPF 50
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0647
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE41.8 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE47.025 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    ISODODECANE (UNII: A8289P68Y2)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURYL METHACRYLATE (UNII: B6L83074BZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    N-VINYLPYRROLIDINONE (UNII: 76H9G81541)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0647-388.7 mL in 1 TUBE; Type 0: Not a Combination Product05/02/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/02/2024
    Labeler - Prime Enterprises (101946028)
    Registrant - Prime Enterprises (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises101946028label(58443-0647) , manufacture(58443-0647) , analysis(58443-0647) , pack(58443-0647)
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