bareminerals ®

bareminerals ®
SPL v4
SPL
SPL Set ID 3c35fd13-1a4b-4acf-ada4-16ee2e52dd94
Route
topical
Published
Effective Date 2021-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (1008 mg) zinc oxide (1744 mg)
Inactive Ingredients
mica ferric oxide red bismuth oxychloride

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-08-01
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
Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months: ask a doctor
  • 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-sleeved shirts, pants, hats, and sunglasses.
Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

bismuth oxychloride, mica, iron oxides.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If 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

Section 55105-1
Active ingredient(s) Purpose
Titanium dioxide 12.6% Sunscreen
Zinc oxide 21.8% Sunscreen
Questions Or Comments?

Call toll free 1-888-795-4747

Principal Display Panel 8 G Jar Label

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

MEDIUM BEIGE 12

net wt. 8 g / 0.28 oz.

61272

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
Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • children under 6 months: ask a doctor
  • 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-sleeved shirts, pants, hats, and sunglasses.
Other Information (Other information)

Protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

bismuth oxychloride, mica, iron oxides.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If 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

Section 55105-1 (55105-1)
Active ingredient(s) Purpose
Titanium dioxide 12.6% Sunscreen
Zinc oxide 21.8% Sunscreen
Questions Or Comments? (Questions or comments?)

Call toll free 1-888-795-4747

Principal Display Panel 8 G Jar Label (PRINCIPAL DISPLAY PANEL - 8 g Jar Label)

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

MEDIUM BEIGE 12

net wt. 8 g / 0.28 oz.

61272

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:26.906728 · Updated: 2026-03-14T23:01:59.101977