Label: BAREMINERALS 5-IN-1 BB ADVANCED PERFORMANCE MINERAL VEIL FINISHING BROAD SPECTRUM SPF 20- 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 March 18, 2014

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient(s)Purpose
    Titanium dioxide 20.0%Sunscreen
    Zinc oxide 20.0%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 product is 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 10 a.m. – 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
  • Inactive ingredients

    silica, dimethicone/vinyl dimethicone crosspolymer, glycerin, magnesium silicate, humic acids, lecithin, betaine, tin oxide, tetrahexyldecyl ascorbate, magnesium ascorbyl phosphate, retinyl retinoate, cyclodextrin, mica, carmine, iron oxides, titanium dioxide, bismuth oxychloride.

  • Other information

    Protect this product from excessive heat and direct sun

  • Questions or comments?

    Call toll free 1-888-795-4747

  • PRINCIPAL DISPLAY PANEL - 6 g Jar Label

    bareMinerals
    5-in-1 BB
    Advanced Performance
    Mineral Veil®
    Finishing Powder
    Broad Spectrum SPF 20

    DIRECTIONS: BUFF ONTO FACE.
    ACTIVE INGREDIENTS: TITANIUM DIOXIDE 20.0%, ZINC OXIDE 20.0%
    WARNING: FOR EXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN. IF SWALLOWED
    GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

    net wt 6 g / 0.21 oz.

    Made in USA

    Dist. by Bare Escentuals Beauty, Inc., SF, CA 94105, USA • London W1D 3QB • 68645

    Principal Display Panel - 6 g Jar Label
  • INGREDIENTS AND APPEARANCE
    BAREMINERALS 5-IN-1 BB ADVANCED PERFORMANCE MINERAL VEIL FINISHING BROAD SPECTRUM SPF 20 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.2 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    BETAINE (UNII: 3SCV180C9W)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    RETINYL RETINOATE (UNII: 5AT5X9J439)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-750-016 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35203/15/2014
    Labeler - Bare Escentuals Beauty, Inc. (087008363)