Label: SOLAR POWDER SPF 20- titanium dioxide powder

  • Category: HUMAN OTC DRUG LABEL

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 June 14, 2012

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  • WHEN USING

    Warning:  For external use only. Do not use on broken or damaged skin.  When using this product - Keep out of eyes - Rinse with water to remove
  • STOP USE

    Stop use and ask a doctor - if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away

  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 3%  Purpose:  Sunscreen

  • PRINCIPAL DISPLAY PANEL


    Image of Box

  • INGREDIENTS AND APPEARANCE
    SOLAR POWDER  SPF 20
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31645-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Talc (UNII: 7SEV7J4R1U)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Dehydroacetic Acid (UNII: 2KAG279R6R)  
    Sorbic Acid (UNII: X045WJ989B)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31645-140-019 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2005
    Labeler - Physicians Formula Inc (021261805)
    Registrant - Physicians Formula Inc (021261805)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tecnocosmesi SA435445218manufacture
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