WARM DARK ORIGINAL (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]

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WARM DARK ORIGINAL (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]
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NDC 98132-148-01, 98132-148-02, 98132-148-03
Set ID 18e93c22-8b3d-4a1e-a449-db070fcfc770
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 7%
    Zinc oxide 20

  • Purpose

    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

    For external use only

    Do not use on damaged or broken skin.

    When using this product: Keep out of Eyes ; Rinse with water to remove

    Stop use and ask a doctor if rash occurs.

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

  • Directions

    For sunscreen use:

    Apply liberally 15 minutes before sun exposure

    Use a water resistant sunscreen if swimming or sweating

    Reapply at least every 2 hours

    Children under 6 months, ask a doctor.

    Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am to 2 pm, wear long-sleeve shirts, pants, hats, and sunglasses.

  • Inactive Ingredients

    Bismuth oxychloride, mica, iron oxides.

  • Other information

    Protect this product from excessive heat and direct sun

  • Questions or comments?

    Call toll free 1-888-795-4747

  • SPL UNCLASSIFIED SECTION

    Bare Escentuals
    MADE IN USA
    Distr. By Bare Escentuals Beauty Inc., San Francisco CA 94104 USA
    London W10 3QB

  • PRINCIPAL DISPLAY PANEL - 8 g Jar Label

    bareMinerals ORIGINAL Foundation
    Broad Spectrum SPF 15

    warm dark

    W45

    net wt 8 g / 0.28 oz.

    Principal Display Panel - 8 g Jar Label
  • INGREDIENTS AND APPEARANCE
    WARM DARK ORIGINAL 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-148
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide7 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Bismuth Oxychloride (UNII: 4ZR792I587)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Mica (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-148-010.75 g in 1 JAR
    2NDC:98132-148-022 g in 1 JAR
    3NDC:98132-148-038 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/05/2010
    Labeler - Bare Escentuals Beauty Inc. (087008363)
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