bareminerals ®

SPL v4

SPL

SPL Set ID b2909888-5a98-4894-a895-230aa53f64d9

Route

topical

Published

Effective Date 2021-08-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

titanium dioxide (2000 mg)

Inactive Ingredients

mica ferric oxide red bismuth oxychloride

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2021-08-01

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
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

Active Ingredient(s)

Titanium dioxide 25%

Questions Or Comments?

Call toll free 1-888-795-4747

Principal Display Panel 8 G Jar Label Medium 10

bareMinerals ^®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

MEDIUM 10

net wt. 8 g / 0.28 oz.

61271

Principal Display Panel 8 G Jar Label Fairly Light 03

bareMinerals ^®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

FAIRLY LIGHT 03

net wt. 8 g / 0.28 oz.

61267

Principal Display Panel 8 G Jar Label Golden Medium 14

bareMinerals ^®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

GOLDEN MEDIUM 14

net wt. 8 g / 0.28 oz.

61273

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
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

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

Titanium dioxide 25%

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-795-4747

Principal Display Panel 8 G Jar Label Medium 10 (PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Medium 10)

bareMinerals ^®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

MEDIUM 10

net wt. 8 g / 0.28 oz.

61271

Principal Display Panel 8 G Jar Label Fairly Light 03 (PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Fairly Light 03)

bareMinerals ^®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

FAIRLY LIGHT 03

net wt. 8 g / 0.28 oz.

61267

Principal Display Panel 8 G Jar Label Golden Medium 14 (PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Golden Medium 14)

bareMinerals ^®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

GOLDEN MEDIUM 14

net wt. 8 g / 0.28 oz.

61273

Advanced Ingredient Data

[{"name": "MICA", "unii": "V8A1AW0880", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BISMUTH OXYCHLORIDE", "unii": "4ZR792I587", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "2000", "strengthDenominator": "8", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MICA", "unii": "V8A1AW0880", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BISMUTH OXYCHLORIDE", "unii": "4ZR792I587", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "2000", "strengthDenominator": "8", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MICA", "unii": "V8A1AW0880", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BISMUTH OXYCHLORIDE", "unii": "4ZR792I587", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "2000", "strengthDenominator": "8", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash occurs", "50567-7": "When using this product keep out of eyes. Rinse with water to remove.", "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 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", "Active ingredient(s)": "Titanium dioxide 25%", "Inactive ingredients": "bismuth oxychloride, mica, iron oxides.", "Questions or comments?": "Call toll free 1-888-795-4747", "PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Medium 10": "bareMinerals ® ORIGINAL FOUNDATION Broad Spectrum SPF 15 MEDIUM 10 net wt. 8 g / 0.28 oz. 61271", "PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Fairly Light 03": "bareMinerals ® ORIGINAL FOUNDATION Broad Spectrum SPF 15 FAIRLY LIGHT 03 net wt. 8 g / 0.28 oz. 61267", "PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Golden Medium 14": "bareMinerals ® ORIGINAL FOUNDATION Broad Spectrum SPF 15 GOLDEN MEDIUM 14 net wt. 8 g / 0.28 oz. 61273"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:27.734854 · Updated: 2026-03-14T23:02:00.533418