Label: FAIR FOUNDATION SPF 15 - zinc oxide and titanium dioxide powder 

  • Label RSS
  • NDC Code(s): 98132-871-18, 98132-879-08
  • 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

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts
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  • Active Ingredients

    Zinc Oxide 19%
    Titanium Dioxide 25%
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  • Purpose

    Sunscreen
    Sunscreen
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  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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  • Warnings

    • Skin cancer/skin aging alert: spending time in the sun increases your risk of cancer and early aging
    • This product has been shown only to help prevent sunburn, not skin cancer or early aging
    • For External use only
    • Do not use on damage or broken skin
    • When using this product keep out of eyes. Rinse with water to remove
    • Stop use and ask doctor if rash occurs
    • Keep out of reach of children
    • If product is swallowed get medical help or contact a poison control center right away

    Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water-resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Sun protection measures. Spending time in the sun increases your risk of skin cancer or early skin aging. To decrease this risk, regularly use a a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long sleeve shirts, pants, hats, and sunglasses
    • Children under 6 month: ask a doctor
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  • Inactive Ingredients

    Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide, Zinc Oxide
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  • Questions or Comments?

    Call toll free 1-888-795-4747
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  • INGREDIENTS AND APPEARANCE
    FAIR FOUNDATION SPF 15 
    zinc oxide, titanium dioxide powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:98132-879
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (Zinc Oxide) Zinc Oxide 19 g  in 100 g
    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:98132-879-08 72 in 1 CASE
    1 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 01/16/2012
    FAIR FOUNDATION SPF 15 
    zinc oxide, titanium dioxide powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:98132-871
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (Zinc Oxide) Zinc Oxide 19 g  in 100 g
    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:98132-871-18 36 in 1 CASE
    1 18 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/16/2010
    Labeler - Bare Escentuals Beauty Inc. (087008363)
    Registrant - Ei Inc. (105803274)
    Establishment
    Name Address ID/FEI Business Operations
    Ei Inc. 105803274 manufacture(98132-879), label(98132-879), pack(98132-879)
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