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

  • NDC Code(s): 31645-202-01, 31645-202-02
  • Packager: Physicians Formula, Inc.
  • 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 September 28, 2021

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  • 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:31645-202
    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:31645-202-021 in 1 CARTON01/01/2018
    1NDC:31645-202-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2018
    Labeler - Physicians Formula, Inc. (021261805)