Label: PURE TRANSFORMATION SHEER FAIR- titanium dioxide and zinc oxide powder
PURE TRANSFORMATION SHEER TAN- 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 August 26, 2013

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

  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 18%
    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

    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 Carton - Fair

    bareMinerals

    PURE
    TRANSFORMATION
    DAY TREATMENT
    BROAD SPECTRUM SPF 20

    includes brush

    net wt 8 g / 0.28 oz.

    Principal Display Panel - 8 g Jar Carton - Fair
  • PRINCIPAL DISPLAY PANEL - 8 g Jar Carton - Tan

    bareMinerals

    PURE
    TRANSFORMATION
    DAY TREATMENT
    BROAD SPECTRUM SPF 20

    includes brush

    net wt 8 g / 0.28 oz.

    Principal Display Panel - 8 g Jar Carton - Tan
  • INGREDIENTS AND APPEARANCE
    PURE TRANSFORMATION SHEER FAIR 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-186
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide18 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:98132-186-038 g in 1 JAR
    2NDC:98132-186-024 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35206/30/2013
    PURE TRANSFORMATION SHEER TAN 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-189
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide18 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:98132-189-038 g in 1 JAR
    2NDC:98132-189-024 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)