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

Pure Transformation Sheer Dark by

Drug Labeling and Warnings

Pure Transformation Sheer Dark by is a Otc medication manufactured, distributed, or labeled by Bare Escentuals Beauty Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 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

INGREDIENTS AND APPEARANCE

PURE TRANSFORMATION SHEER LIGHT 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-187
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	15 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-187-03	8 g in 1 JAR
2	NDC: 98132-187-02	4 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/30/2013

PURE TRANSFORMATION SHEER MEDIUM 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-188
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	15 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-188-03	8 g in 1 JAR
2	NDC: 98132-188-02	4 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/30/2013

PURE TRANSFORMATION SHEER DARK 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	15 g  in 100 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-191-03	8 g in 1 JAR
2	NDC: 98132-191-02	4 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/30/2013

Labeler - Bare Escentuals Beauty Inc. (087008363)