BAREMINERALS SPF 20 CORRECTING CONCEALER DARK 2- titanium dioxide cream BAREMINERALS SPF 20 CORRECTING CONCEALER DEEP 2- titanium dioxide cream

BAREMINERALS SPF 20 CORRECTING CONCEALER by

Drug Labeling and Warnings

BAREMINERALS SPF 20 CORRECTING CONCEALER by is a Otc medication manufactured, distributed, or labeled by Orveon Global US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(s)

Titanium dioxide 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 product is 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 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

isodecyl isononanoate, phenyl trimethicone, isocetyl alcohol, hydrogenated polyisobutene, polymethylsilsesquioxane, HDI/trimethylol hexyllactone crosspolymer, polyethylene, trioctyldodecyl citrate, calcium aluminum borosilicate, silica, euphorbia cerifera (candelilla) wax, octadecenedioic acid, tocopheryl acetate, cetyl esters, ethylene/propylene/styrene copolymer, butylene/ethylene/styrene copolymer, lecithin, lauryl PCA, hydrogen dimethicone, VP/hexadecene copolymer, alumina, ethylhexyl palmitate, saccharomyces/copper ferment, lactobacillus/lemon peel ferment extract, phenoxyethanol.

may contain: mica, titanium dioxide, iron oxides, bismuth oxychloride.

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 - Dark 2

bareMinerals ®

CORRECTING
CONCEALER
BROAD SPECTRUM SPF 20

net wt 2 g / 0.07 oz.

PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Deep 2

bareMinerals ®

CORRECTING
CONCEALER
BROAD SPECTRUM SPF 20

net wt 2 g / 0.07 oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS SPF 20 CORRECTING CONCEALER  DARK 2
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.1 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ISODECYL ISONONANOATE (UNII: 4X46Q4U00Z)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISOCETYL ALCOHOL (UNII: 1800H64066)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CANDELILLA WAX (UNII: WL0328HX19)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-001-40	1 in 1 CARTON	04/26/2021
1		2 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/26/2021

BAREMINERALS SPF 20 CORRECTING CONCEALER  DEEP 2
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.1 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ISODECYL ISONONANOATE (UNII: 4X46Q4U00Z)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISOCETYL ALCOHOL (UNII: 1800H64066)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CANDELILLA WAX (UNII: WL0328HX19)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
LAURYL PIDOLATE (UNII: 29C5O2BJYA)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-002-40	1 in 1 CARTON	04/26/2021
1		2 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/26/2021

Labeler - Orveon Global US LLC (118344494)