4 IN 1 PRESSED MINERAL SPF 15 TAN (TITANIUM DIOXIDE) POWDER [PUR MINERALS]

4 IN 1 PRESSED MINERAL SPF 15 TAN (TITANIUM DIOXIDE) POWDER [PUR MINERALS]
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NDC 67345-0785-0
Set ID 5aa13f23-73cc-4208-ba8c-b1ba68b1e092
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

    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 TAN 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67345-0785
    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:67345-0785-08 g in 1 CASE
    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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