OTC Medication Information: BAREMINERALS SPF 20 CORRECTING CONCEALER Dark 2

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

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

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 -- Dark 2
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2 g Container Carton — Deep 2

bareMinerals®

CORRECTING
CONCEALER
BROAD SPECTRUM SPF 20

net wt 2 g / 0.07 oz.

PRINCIPAL DISPLAY PANEL -- 2 g Container Carton -- Deep 2
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.1 g in 2 g
Inactive Ingredients
Ingredient Name Strength
Phenyl Trimethicone
Isodecyl Isononanoate
Trioctyldodecyl Citrate
.ALPHA.-TOCOPHEROL ACETATE, DL-
Phenoxyethanol
HYDROGEN DIMETHICONE (13 CST)
SILICON DIOXIDE
ALUMINUM OXIDE
Isocetyl Alcohol
HYDROGENATED POLYBUTENE (1300 MW)
HIGH DENSITY POLYETHYLENE
Octadecenedioic Acid
CETYL ESTERS WAX
CANDELILLA WAX
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
LAURYL PIDOLATE
Ethylhexyl Palmitate
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER
Mica
FERRIC OXIDE RED
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
Calcium Aluminum Borosilicate
Bismuth Oxychloride
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:98132-001-40 1 CONTAINER in 1 CARTON contains a CONTAINER
1 2 g in 1 CONTAINER This package is contained within the CARTON (98132-001-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.1 g in 2 g
Inactive Ingredients
Ingredient Name Strength
Phenyl Trimethicone
Isodecyl Isononanoate
Trioctyldodecyl Citrate
.ALPHA.-TOCOPHEROL ACETATE, DL-
Phenoxyethanol
HYDROGEN DIMETHICONE (13 CST)
SILICON DIOXIDE
ALUMINUM OXIDE
Isocetyl Alcohol
HYDROGENATED POLYBUTENE (1300 MW)
HIGH DENSITY POLYETHYLENE
Octadecenedioic Acid
CETYL ESTERS WAX
CANDELILLA WAX
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
LAURYL PIDOLATE
Ethylhexyl Palmitate
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER
Mica
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
Calcium Aluminum Borosilicate
FERRIC OXIDE RED
Bismuth Oxychloride
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:98132-002-40 1 CONTAINER in 1 CARTON contains a CONTAINER
1 2 g in 1 CONTAINER This package is contained within the CARTON (98132-002-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/26/2021
Labeler — Bare Escentuals Beauty, Inc. (087008363)
Registrant — SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 07/2021 Bare Escentuals Beauty, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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