FAIR FOUNDATION SPF 15 (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]

FAIR FOUNDATION SPF 15 (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]
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NDC 98132-871-18, 98132-879-08
Set ID 491a5768-1aad-458e-b4d6-72ea085d1d9f
Category HUMAN OTC DRUG LABEL
Packager Bare Escentuals Beauty Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • Active Ingredients

    Zinc Oxide 19%
    Titanium Dioxide 25%
  • Purpose

    Sunscreen
    Sunscreen
  • 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
  • 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
  • Inactive Ingredients

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

    Call toll free 1-888-795-4747
  • PRINCIPAL DISPLAY PANEL

    LabelLabel continuedLabel continued

  • INGREDIENTS AND APPEARANCE
    FAIR FOUNDATION SPF 15 
    zinc oxide, titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-879
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide19 g  in 100 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-879-0872 in 1 CASE
    18 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/16/2012
    FAIR FOUNDATION SPF 15 
    zinc oxide, titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-871
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide19 g  in 100 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-871-1836 in 1 CASE
    118 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/16/2010
    Labeler - Bare Escentuals Beauty Inc. (087008363)
    Registrant - Ei Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei Inc.105803274manufacture(98132-879) , label(98132-879) , pack(98132-879)

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