Label: PURE TRANSFORMATION SHEER LIGHT- titanium dioxide and zinc oxide powder
PURE TRANSFORMATION SHEER MEDIUM- titanium dioxide and zinc oxide powder
PURE TRANSFORMATION SHEER DARK- 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 September 16, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium Dioxide 15%   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 - Jar Label - SHEER LIGHT

    bareMinerals

    PURE TRANSFORMATION
    DAY TREATMENT
    BROAD SPECTRUM SPF 20
    with ActiveSoil Complex

    SHEER LIGHT

    ACTIVE INGREDIENT(S): TITANIUM DIOXIDE 15%, 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.

    66161

    Principal Display Panel - Jar Label - SHEER LIGHT
  • PRINCIPAL DISPLAY PANEL - Jar Label - SHEER MEDIUM

    bareMinerals

    PURE TRANSFORMATION
    DAY TREATMENT
    BROAD SPECTRUM SPF 20
    with ActiveSoil Complex

    SHEER MEDIUM

    ACTIVE INGREDIENT(S): TITANIUM DIOXIDE 15%, 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.

    66162

    Principal Display Panel - Jar Label - SHEER MEDIUM
  • PRINCIPAL DISPLAY PANEL - Jar Label - SHEER DARK

    bareMinerals

    PURE TRANSFORMATION
    DAY TREATMENT
    BROAD SPECTRUM SPF 20
    with ActiveSoil Complex

    SHEER DARK

    ACTIVE INGREDIENT(S): TITANIUM DIOXIDE 15%, 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.

    66164

    Principal Display Panel - Jar Label - SHEER DARK
  • INGREDIENTS AND APPEARANCE
    PURE TRANSFORMATION SHEER LIGHT 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-187
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide15 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:98132-187-038 g in 1 JAR
    2NDC:98132-187-024 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 MEDIUM 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide15 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:98132-188-038 g in 1 JAR
    2NDC:98132-188-024 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 DARK 
    titanium dioxide and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide15 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:98132-191-038 g in 1 JAR
    2NDC:98132-191-024 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)
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