Label: MINERAL WEAR TALC FREE MINERAL FACE POWDER SPF 16- titanium dioxide, zinc oxide powder

  • NDC Code(s): 69514-304-01, 69514-304-02
  • Packager: Markwins Beauty Brands
  • 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 January 24, 2023

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  • DOSAGE & ADMINISTRATION

    apply liberally 15 minutes before sun exposure
    use a water resistant sunscreen if swimming or sweating
    reapply 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 value 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-sleeved shirts, pants, hats, and sunglasses

  • WARNINGS

    For external use only

    Do not use on damage 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

  • INACTIVE INGREDIENT

    Mica, Squalane, Silica, Lauroyl Lysine, Kaolin, Boron Nitride, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, o-Cymen-5-ol, Tocopheryl Acetate. May Contain/Peut Contenir: Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

  • INDICATIONS & USAGE

    helps prevent sunburn
    If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Sunscreen

  • ACTIVE INGREDIENT

    Titanium Dioxide 6%

    Zinc Oxide 4.2%

  • PRINCIPAL DISPLAY PANEL

    Package Label PDP

  • INGREDIENTS AND APPEARANCE
    MINERAL WEAR TALC FREE MINERAL FACE POWDER  SPF 16
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69514-304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SQUALANE (UNII: GW89575KF9)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    KAOLIN (UNII: 24H4NWX5CO)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69514-304-021 in 1 CARTON01/01/2023
    1NDC:69514-304-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2023
    Labeler - Markwins Beauty Brands (078890119)
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