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

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

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

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.

Description

Drug Facts

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

Active Ingredient(s)

Titanium dioxide 5%

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

Warnings

For external use only

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
Purpose

Sunscreen

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

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.

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

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

Titanium dioxide 5%

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

All Sections (JSON)