PURE TRANSFORMATION SHEER CLEAR (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]

PURE TRANSFORMATION SHEER CLEAR (TITANIUM DIOXIDE AND ZINC OXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]
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NDC 98132-190-03
Set ID 09c80c29-2996-483b-a39a-779a10cb23b2
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

    Titanium Dioxide 19%   Purpose: Sunscreen
    Zinc oxide 5%   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

    Boron nitride, glycerin, methylcellulose, maltodextrin, ascorbic acid, illite, trimyrstintin, betaine, phylantus embilica frut extract, sodium hyaluronate, hydrogenated lecithin, aloe barbensis leaf extract, retintyl palmitate, aluminum dimyristate, triethoxycaprylsilane, cyclopia intermedia leaf extract, cameria sinensis leaf extract, ectoin, tocopheryl acetate, triticum vulgare (wheat germ extract), disodium stearoyl glutamate, ferulic acid, litchi chinesis fruit extract, oryza sativa (rice) extract, disodium EDTA, rosmarinus officinalis (rosemary) extract, tetrahydrobisdemthoxydiferuloylmethane, dipotassium glycyrrhizinate, aspalathus linearis leaf extract. May contain: mica. bismuth oxychloride, titanium dioxide, 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 - 8g Jar Label

    bareMinerals

    PURE TRANSFORMATION
    DAY TREATMENT
    BROAD SPECTRUM SPF 20

    with ActiveSoil Complex

    CLEAR

    ACTIVE INGREDIENT(S): TITANIUM DIOXIDE 19%, ZINC OXIDE 5%

    See box for complete drug facts information.

    WARNING: For external use only. Keep out of reach of
    children. If swallowed get medical help or contact
    a poison control center right away.

    69508

    Principal Display Panel - 8g Jar Label
  • INGREDIENTS AND APPEARANCE
    PURE TRANSFORMATION SHEER CLEAR 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide19 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    boron nitride (UNII: 2U4T60A6YD)  
    glycerin (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    magnesium silicate (UNII: 9B9691B2N9)  
    maltodextrin (UNII: 7CVR7L4A2D)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    ascorbic acid (UNII: PQ6CK8PD0R)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    TRIMYRISTIN (UNII: 18L31PSR28)  
    betaine (UNII: 3SCV180C9W)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    ALOE (UNII: V5VD430YW9)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    CYCLOPIA INTERMEDIA LEAF (UNII: 29UXG2GG8O)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ectoine (UNII: 7GXZ3858RY)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    WHEAT GERM (UNII: YR3G369F5A)  
    disodium stearoyl glutamate (UNII: 45ASM2L11M)  
    ferulic acid (UNII: AVM951ZWST)  
    LITCHI FRUIT (UNII: Y5P61KP51E)  
    rice germ (UNII: 7N2B70SFEZ)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    rosemary (UNII: IJ67X351P9)  
    TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE (UNII: 973IBV8W7I)  
    glycyrrhizinate dipotassium (UNII: CA2Y0FE3FX)  
    aspalathus linearis leaf (UNII: H7UGK1GJCU)  
    mica (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:98132-190-038 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/30/2013
    Labeler - Bare Escentuals Beauty Inc. (087008363)

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