Label: FAIRLY LIGHT FOUNDATION SPF 15 - titanium dioxide powder

  • NDC Code(s): 98132-872-08, 98132-872-18
  • Packager: Bare Escentuals Beauty Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts
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  • Active Ingredients

    Titanium Dioxide 25%
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  • Purpose

    Sunscreen
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  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
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  • Warnings

    For External use only
    When using this product keep out of eyes. Rinse with water to remove.
    Stop use and ask doctor if rash or irritation develops and last
    Keep out of reach of children
    If swallowed, get medical help or contact a Poison Control Center right away

    Directions

    Apply evenly before sun exposure as needed
    Children under 6 month of age: ask a doctor
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  • Inactive Ingredients

    Bismuth Oxychloride, Iron Oxides, Mica
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  • Questions or Comments?

    Store at room temperature (59F-88F)
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  • INGREDIENTS AND APPEARANCE
    FAIRLY LIGHT FOUNDATION SPF 15 
    titanium dioxide powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:98132-872
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 25 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    MICA  
    BISMUTH OXYCHLORIDE  
    BROWN IRON OXIDE  
    FERRIC OXIDE YELLOW  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:98132-872-18 36 in 1 CASE
    1 18 g in 1 JAR
    2 NDC:98132-872-08 144 in 1 CASE
    2 8 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/06/2010
    Labeler - Bare Escentuals Beauty Inc. (087008363)
    Registrant - Ei Inc. (105803274)
    Establishment
    Name Address ID/FEI Business Operations
    Ei Inc. 105803274 manufacture(98132-872), label(98132-872), pack(98132-872)
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