Bareminerals ®

Bareminerals ®
SPL v4
SPL
SPL Set ID 6845acee-5a3f-4c8d-9386-8823b30373f3
Route
TOPICAL
Published
Effective Date 2021-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (0.1 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-26

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

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
Other Information

Protect this product from excessive heat and direct sun

Active Ingredient(s)

Titanium dioxide 5%

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.

Questions Or Comments?

Call toll free 1-888-795-4747

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.


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

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
Other Information (Other information)

Protect this product from excessive heat and direct sun

Active Ingredient(s) (Active ingredient(s))

Titanium dioxide 5%

Inactive Ingredients (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.

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-795-4747

Principal Display Panel 2 G Container Carton Dark 2 (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 (PRINCIPAL DISPLAY PANEL - 2 g Container Carton - Deep 2)

bareMinerals ®

CORRECTING

CONCEALER

BROAD SPECTRUM SPF 20

net wt 2 g / 0.07 oz.


Advanced Ingredient Data


Raw Label Data

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