BAREMINERALS SPF 20 CORRECTING CONCEALER- titanium dioxide cream

BareMinerals by

Drug Labeling and Warnings

BareMinerals 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

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

• Skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early aging
• This product has been shown only to help prevent sunburn, not skin cancer or early aging
• 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 product is swallowed, get medical help or contact a poison control center right away

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water-resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• 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 10 a.m. – 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor

Inactive ingredients

Alumina, Bismuth Oxychloride, Butylene/Ethylene/Styrene Copolymer, Calcium Aluminum Borosilicate, Cetyl Esters, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) Wax (Candelilla Cera / Cire de Candelilla), HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogen Dimethicone, Hydrogenated Polyisobutene, Iron Oxides, Isocetyl Alcohol, Isodecyl Isononanoate, Lactobacillus/Lemon Peel Ferment Extract, Lauryl PCA, Lecithin, Mica, Octadecenedioic Acid, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Polymethylsilsesquioxane, Saccharomyces/Copper Ferment, Silica, Titanium Dioxide, Tocopheryl Acetate, Trioctyldodecyl Citrate, VP/Hexadecene Copolymer.

Other information

• Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-795-4747

SPL UNCLASSIFIED SECTION

Dist. by Bare Escentuals Beauty, Inc., SF, CA 94105 USA

PRINCIPAL DISPLAY PANEL - 2 g Container Carton - LIGHT 1

bareMinerals®

SPF 20 CORRECTING
CONCEALER

2 g / 0.07 Oz.

PRINCIPAL DISPLAY PANEL - 2 g Container Carton - LIGHT 2

bareMinerals®

SPF 20 CORRECTING
CONCEALER

2 g / 0.07 Oz.

PRINCIPAL DISPLAY PANEL - 2 g Container Carton - MEDIUM 1

bareMinerals®

SPF 20 CORRECTING
CONCEALER

2 g / 0.07 Oz.

PRINCIPAL DISPLAY PANEL - 2 g Container Carton - MEDIUM 2

bareMinerals®

SPF 20 CORRECTING
CONCEALER

2 g / 0.07 Oz.

PRINCIPAL DISPLAY PANEL - 2 g Container Carton - TAN 1

bareMinerals®

SPF 20 CORRECTING
CONCEALER

2 g / 0.07 Oz.

PRINCIPAL DISPLAY PANEL - 2 g Container Carton - TAN 2

bareMinerals®

SPF 20 CORRECTING
CONCEALER

2 g / 0.07 Oz.

PRINCIPAL DISPLAY PANEL - 2 g Container Carton - DARK 2

bareMinerals®

SPF 20 CORRECTING
CONCEALER

2 g / 0.07 Oz.

PRINCIPAL DISPLAY PANEL - 2 g Container Carton - DEEP 2

bareMinerals®

SPF 20 CORRECTING
CONCEALER

2 g / 0.07 Oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS   SPF 20 CORRECTING CONCEALER
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-664
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.3 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lecithin, Soybean (UNII: 1DI56QDM62)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Isocetyl Alcohol (UNII: 1800H64066)
High Density Polyethylene (UNII: UG00KM4WR7)
Octadecenedioic Acid (UNII: 565ZMT5QRG)
Candelilla Wax (UNII: WL0328HX19)
Lauryl PCA (UNII: 29C5O2BJYA)
Ethylhexyl Palmitate (UNII: 2865993309)
Mica (UNII: V8A1AW0880)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Bismuth Oxychloride (UNII: 4ZR792I587)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	BROWN (Light 1)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-664-01	1 in 1 CARTON
1		2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/26/2012

BAREMINERALS   SPF 20 CORRECTING CONCEALER
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-665
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.3 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lecithin, Soybean (UNII: 1DI56QDM62)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Isocetyl Alcohol (UNII: 1800H64066)
High Density Polyethylene (UNII: UG00KM4WR7)
Octadecenedioic Acid (UNII: 565ZMT5QRG)
Candelilla Wax (UNII: WL0328HX19)
Lauryl PCA (UNII: 29C5O2BJYA)
Ethylhexyl Palmitate (UNII: 2865993309)
Mica (UNII: V8A1AW0880)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Bismuth Oxychloride (UNII: 4ZR792I587)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	BROWN (Light 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-665-01	1 in 1 CARTON
1		2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/26/2012

BAREMINERALS   SPF 20 CORRECTING CONCEALER
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-666
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.3 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lecithin, Soybean (UNII: 1DI56QDM62)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Isocetyl Alcohol (UNII: 1800H64066)
High Density Polyethylene (UNII: UG00KM4WR7)
Octadecenedioic Acid (UNII: 565ZMT5QRG)
Candelilla Wax (UNII: WL0328HX19)
Lauryl PCA (UNII: 29C5O2BJYA)
Ethylhexyl Palmitate (UNII: 2865993309)
Mica (UNII: V8A1AW0880)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Bismuth Oxychloride (UNII: 4ZR792I587)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	BROWN (Medium 1)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-666-01	1 in 1 CARTON
1		2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/26/2012

BAREMINERALS   SPF 20 CORRECTING CONCEALER
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-667
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.3 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lecithin, Soybean (UNII: 1DI56QDM62)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Isocetyl Alcohol (UNII: 1800H64066)
High Density Polyethylene (UNII: UG00KM4WR7)
Octadecenedioic Acid (UNII: 565ZMT5QRG)
Candelilla Wax (UNII: WL0328HX19)
Lauryl PCA (UNII: 29C5O2BJYA)
Ethylhexyl Palmitate (UNII: 2865993309)
Mica (UNII: V8A1AW0880)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Bismuth Oxychloride (UNII: 4ZR792I587)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	BROWN (Medium 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-667-01	1 in 1 CARTON
1		2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/26/2012

BAREMINERALS   SPF 20 CORRECTING CONCEALER
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-668
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.3 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lecithin, Soybean (UNII: 1DI56QDM62)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Isocetyl Alcohol (UNII: 1800H64066)
High Density Polyethylene (UNII: UG00KM4WR7)
Octadecenedioic Acid (UNII: 565ZMT5QRG)
Candelilla Wax (UNII: WL0328HX19)
Lauryl PCA (UNII: 29C5O2BJYA)
Ethylhexyl Palmitate (UNII: 2865993309)
Mica (UNII: V8A1AW0880)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Bismuth Oxychloride (UNII: 4ZR792I587)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	BROWN (Tan 1)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-668-01	1 in 1 CARTON
1		2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/26/2012

BAREMINERALS   SPF 20 CORRECTING CONCEALER
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-669
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.3 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lecithin, Soybean (UNII: 1DI56QDM62)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Isocetyl Alcohol (UNII: 1800H64066)
High Density Polyethylene (UNII: UG00KM4WR7)
Octadecenedioic Acid (UNII: 565ZMT5QRG)
Candelilla Wax (UNII: WL0328HX19)
Lauryl PCA (UNII: 29C5O2BJYA)
Ethylhexyl Palmitate (UNII: 2865993309)
Mica (UNII: V8A1AW0880)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Bismuth Oxychloride (UNII: 4ZR792I587)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	BROWN (Tan 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-669-01	1 in 1 CARTON
1		2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/26/2012

BAREMINERALS   SPF 20 CORRECTING CONCEALER
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-670
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.3 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lecithin, Soybean (UNII: 1DI56QDM62)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Isocetyl Alcohol (UNII: 1800H64066)
High Density Polyethylene (UNII: UG00KM4WR7)
Octadecenedioic Acid (UNII: 565ZMT5QRG)
Candelilla Wax (UNII: WL0328HX19)
Lauryl PCA (UNII: 29C5O2BJYA)
Ethylhexyl Palmitate (UNII: 2865993309)
Mica (UNII: V8A1AW0880)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Bismuth Oxychloride (UNII: 4ZR792I587)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	BROWN (Dark 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-670-01	1 in 1 CARTON
1		2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/26/2012

BAREMINERALS   SPF 20 CORRECTING CONCEALER
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-671
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.3 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lecithin, Soybean (UNII: 1DI56QDM62)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Isocetyl Alcohol (UNII: 1800H64066)
High Density Polyethylene (UNII: UG00KM4WR7)
Octadecenedioic Acid (UNII: 565ZMT5QRG)
Candelilla Wax (UNII: WL0328HX19)
Lauryl PCA (UNII: 29C5O2BJYA)
Ethylhexyl Palmitate (UNII: 2865993309)
Mica (UNII: V8A1AW0880)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Bismuth Oxychloride (UNII: 4ZR792I587)
Aluminum Oxide (UNII: LMI26O6933)

Product Characteristics
Color	BROWN (Deep 2)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-671-01	1 in 1 CARTON
1		2 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/26/2012

Labeler - Bare Escentuals Beauty Inc. (087008363)