FAIRLY LIGHT FOUNDATION SPF 15 (TITANIUM DIOXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]

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FAIRLY LIGHT FOUNDATION SPF 15 (TITANIUM DIOXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]
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NDC 98132-872-08, 98132-872-18
Set ID 687b3d84-569a-4408-b9b8-3d6a024eee09
Category HUMAN OTC DRUG LABEL
Packager Bare Escentuals Beauty Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • Active Ingredients

    Titanium Dioxide 25%
  • Purpose

    Sunscreen
  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
  • 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
  • Inactive Ingredients

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

    Store at room temperature (59F-88F)
  • PRINCIPAL DISPLAY PANEL

    Label-8 gLabel-8g continued

    Label-18gLabel-8g continued

  • INGREDIENTS AND APPEARANCE
    FAIRLY LIGHT FOUNDATION SPF 15 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-872
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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:98132-872-1836 in 1 CASE
    118 g in 1 JAR
    2NDC:98132-872-08144 in 1 CASE
    28 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/06/2010
    Labeler - Bare Escentuals Beauty Inc. (087008363)
    Registrant - Ei Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei Inc.105803274manufacture(98132-872) , label(98132-872) , pack(98132-872)
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