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 
Bare Escentuals Beauty Inc.

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.

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Pure Transformation Day Treatment Broad Spectrum SPF 20 in Light (Medium or Dark)

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

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
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)

Revised: 9/2013
Document Id: 5a51c4b8-6823-4813-9a24-05e9c2289cf5
Set id: 5c4f8d4b-8e61-4190-89b9-2a5bde88d2b1
Version: 1
Effective Time: 20130916
 
Bare Escentuals Beauty Inc.