Label: BAREMINERALS- titanium dioxide and zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 July 26, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Titanium Dioxide 25%Sunscreen
    Zinc Oxide 10%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 a doctor if

    • Rash or irritation develops and lasts

    • 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
  • Other Information

    • Store at room temperature (59°-88°F)
    • Adverse Even Reporting: 71 Stevenson St., 22 Fl., SF, CA 94105. Attn: OTC
  • Inactive Ingredients

    Silica, Corn Starch Modified, Zea Mays (Corn) Starch, Zinc Stearate. May contain: Iron Oxides.

  • SPL UNCLASSIFIED SECTION

    Dist. by Bare Escentuals Beauty, Inc., San Francisco, CA 94105, USA

  • PRINCIPAL DISPLAY PANEL - 6 g Jar

    bareMinerals
    SPF 25 BRONZING Mineral Veil

    SPF 25 bronzing
    mineral veil

    6 g / 0.21 Oz.

    Principal Display Panel - 6 g Jar
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS   BRONZING MINERAL VEIL
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-161
    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
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Zinc Stearate (UNII: H92E6QA4FV)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-161-036 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/05/2011
    Labeler - Bare Escentuals Beauty Inc. (087008363)
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