bareminerals ®

bareminerals ®
SPL v4
SPL
SPL Set ID 4054b48e-d8be-4542-9b43-4437c250579b
Route
topical
Published
Effective Date 2021-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (1440 mg)
Inactive Ingredients
mica titanium dioxide 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

iron oxides, mica, bismuth oxychloride, titanium dioxide.

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)

Zinc oxide 18%

Questions Or Comments?

Call toll free 1-888-795-4747

Principal Display Panel 8 G Jar Label

bareMinerals ®

ORIGINAL FOUNDATION

Broad Spectrum SPF 15

DEEPEST DEEP 30

net wt. 8 g / 0.28 oz.

61283


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)

iron oxides, mica, bismuth oxychloride, titanium dioxide.

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))

Zinc oxide 18%

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

DEEPEST DEEP 30

net wt. 8 g / 0.28 oz.

61283


Advanced Ingredient Data


Raw Label Data

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