Label: UNITED SPIRIT SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 3, 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 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 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 a broad spectrum SPF of 15 or higher and other sun protection measures including: •limit time in the sun, especially from 10 am to 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, Ethyl Ferulate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Phenoxyethanol, Polyglyceryl-3 Distearate, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, VP/Acrylates/Lauryl Methacrylate Copolymer, Water

  • Other Information

    protect this product from excessive heat and direct sun

  • Warrior No Trace Tinted Mineral Sunscreen Broad Spectrum SPF 50 Lotion

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    UNITED SPIRIT  SUNSCREEN BROAD SPECTRUM SPF 50
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0628
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE44.145 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE39.24 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISODODECANE (UNII: A8289P68Y2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    N-VINYLPYRROLIDINONE (UNII: 76H9G81541)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LAURYL METHACRYLATE (UNII: B6L83074BZ)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Product Characteristics
    Colorbrown (Light Brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0628-388.7 mL in 1 TUBE; Type 0: Not a Combination Product08/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/03/2023
    Labeler - Prime Enterprises (101946028)
    Registrant - Prime Enterprises (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises101946028manufacture(58443-0628) , label(58443-0628) , analysis(58443-0628) , pack(58443-0628)
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