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

  • NDC Code(s): 58443-0644-3
  • Packager: Prime Enterprises Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2023

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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 useon damaged or broken skin

    When using this productkeep 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 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 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • 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, Decyl Glucoside, Ethyl Ferulate, Glycerin, Isododecane, Isohexadecane, Phenoxyethanol, Polyglyceryl-3 Distearate, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, VP/Acrylates/Lauryl Methacrylate Polymer, Water

  • Other Information

    • protect this product from excessive heat and direct sun
  • Warrior 50 Broad Spectrum SPF 50 Sunscreen Minerals Formula

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    WARRIOR  BROAD SPECTRUM SPF 50 SUNSCREEN MINERALS FORMULA
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0644
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE44.46 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE41.4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    VINYL ACETATE (UNII: L9MK238N77)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    N-VINYLPYRROLIDINONE (UNII: 76H9G81541)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISODODECANE (UNII: A8289P68Y2)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0644-388.7 mL in 1 TUBE; Type 0: Not a Combination Product03/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/15/2022
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0644) , manufacture(58443-0644) , label(58443-0644) , analysis(58443-0644)
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