Label: PURMINERALS 4 IN 1 MAKEUP SPF 15 TAN- titanium dioxide powder

  • 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 April 22, 2011

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  • 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:67345-0513
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.387 g  in 4.3 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:67345-0513-04.3 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/17/2006
    Labeler - PURMINERALS (780516402)
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