Label: 4 IN 1 PRESSED MINERAL SPF 15 MEDIUM DARK- 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 September 15, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient : Titanium Dioxide 9 %

  • PURPOSE

    Purpose : Sunscreen

  • STOP USE

    Discontinue use If rash or irritation develops and increases. If irritation persists, consult a health care practitioner or Contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children .


  • INACTIVE INGREDIENT

    Inactive Ingredients : Mica , Boron Nitride , Caprylic/Capric Triglyceride , Bismuth Oxychloride , Zinc Stearate , Magnesium Silicate , Magnesium Carbonate ,Sodium Starch Octenylsuccinate, Mannitol,

    Sodium Gluconate , Citric Acid, Sodium Citrate , Walthena Indica Leaf Extract , Dextrin , Ferulic Acid, L-Lactic Acid, Butyrospermum Parkii (Shea Butter) , Silica, Thioctic Acid,Sodium Hyarluronate, Retinol,

    L-Ascorbic Acid, Ceramide 6 II , Magnolia Officinalis Bark Extract, Vitis Vinifera (Grape) Seed Extract , Tocopherol , Lecithin , Maltodextrin , Vitis Vinifera (Grape) Fruit Skin, Glycerin, Palmitoyl Tripeptide-5,

    L-Glucothione, Aloe Barbadensis Leaf Extract, Hydrated Silica , Tocopheryl Acetate , Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambus Vulgaris Leaf/Stem Extract, Magnesium Carbonate ,

    Iron oxide , May contain : Titanium Dioxide, Ultramarines.


  • WARNINGS

    For external use only. Please avoid contact inside eyes. Rinse with water to remove.

  • PRINCIPAL DISPLAY PANEL

    Image of Label

  • INGREDIENTS AND APPEARANCE
    4 IN 1 PRESSED MINERAL SPF 15 MEDIUM DARK 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67345-6085
    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:67345-6085-04.3 g in 1 CARTRIDGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/15/2011
    Labeler - PUR MINERALS (780516402)
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