PURMINERALS 4 IN 1 MAKEUP SPF 15 TAN (TITANIUM DIOXIDE) POWDER [PUR MINERALS]

PURMINERALS 4 IN 1 MAKEUP SPF 15 TAN (TITANIUM DIOXIDE) POWDER [PUR MINERALS]
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NDC 67345-0631-0
Set ID e5a76e08-c5fd-46fc-906b-880069f66ec4
Category HUMAN OTC DRUG LABEL
Packager PUR MINERALS
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient : Titanium Dioxide 9 %

  • PURPOSE

    Purpose : Sunscreen

  • STOP USE

    Stop Use and Ask a Doctor : If rash or irritation develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children . If swallowed , get medical help or contact a Poison Control Center right away.


  • INACTIVE INGREDIENT

    Inactive Ingredients : Mica , Boron Nitride , Caprylic/Capric Triglyceride , Bismuth Oxychloride , Zinc Stearate , Magnesium Silicate , Magnesium Carbonate , Silica , Shea Butter ( Butyrospermum Parkii ) , Tocopheryl Acetate , Iron oxide , May contain ultramarines.


  • PRINCIPAL DISPLAY PANEL

    Image of Label

  • INGREDIENTS AND APPEARANCE
    PURMINERALS 4 IN 1 MAKEUP SPF 15 TAN 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67345-0631
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.72 g  in 8 g
    Inactive Ingredients
    Ingredient NameStrength
    Mica (UNII: V8A1AW0880)  
    Boron Nitride (UNII: 2U4T60A6YD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Zinc Stearate (UNII: H92E6QA4FV)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Shea Butter (UNII: K49155WL9Y)  
    Acetate Ion (UNII: 569DQM74SC)  
    Iron (UNII: E1UOL152H7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67345-0631-08 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/17/2006
    Labeler - PUR MINERALS (780516402)

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