bareminerals ®

bareminerals ®
SPL v4
SPL
SPL Set ID 828fe263-f223-45c3-9710-fd8d59ad56b1
Route
topical
Published
Effective Date 2021-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (560 mg) zinc oxide (1600 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, iron oxides, mica

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 7% Sunscreen
Zinc oxide 20% Sunscreen
Questions Or Comments?

Call toll free 1-888-795-4747

Principal Display Panel 8 G Jar Label Warm Tan 22

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

WARM TAN 22

net wt. 8 g / 0.28 oz.

61277

Principal Display Panel 8 G Jar Label Warm Dark 26

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

WARM DARK 26

net wt. 8 g / 0.28 oz.

61281

Principal Display Panel 8 G Jar Label Warm Deep 27

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

WARM DEEP 27

net wt. 8 g / 0.28 oz.

61285

Principal Display Panel 8 G Jar Label Golden Dark 25

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

GOLDEN DARK 25

net wt. 8 g / 0.28 oz.

61280

Principal Display Panel 8 G Jar Label Medium Dark 23

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

MEDIUM DARK 23

net wt. 8 g / 0.28 oz.

61279


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, iron oxides, mica

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 7% Sunscreen
Zinc oxide 20% Sunscreen
Questions Or Comments? (Questions or comments?)

Call toll free 1-888-795-4747

Principal Display Panel 8 G Jar Label Warm Tan 22 (PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Warm Tan 22)

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

WARM TAN 22

net wt. 8 g / 0.28 oz.

61277

Principal Display Panel 8 G Jar Label Warm Dark 26 (PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Warm Dark 26)

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

WARM DARK 26

net wt. 8 g / 0.28 oz.

61281

Principal Display Panel 8 G Jar Label Warm Deep 27 (PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Warm Deep 27)

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

WARM DEEP 27

net wt. 8 g / 0.28 oz.

61285

Principal Display Panel 8 G Jar Label Golden Dark 25 (PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Golden Dark 25)

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

GOLDEN DARK 25

net wt. 8 g / 0.28 oz.

61280

Principal Display Panel 8 G Jar Label Medium Dark 23 (PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Medium Dark 23)

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

MEDIUM DARK 23

net wt. 8 g / 0.28 oz.

61279


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)