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

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 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
Warnings

For external use only

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.

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

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 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
Warnings

For external use only

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.

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