baremineral original spf 15 foundation fair

baremineral original spf 15 foundation fair
SPL v4
SPL
SPL Set ID 491a5768-1aad-458e-b4d6-72ea085d1d9f
Route
topical
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (19 g) titanium dioxide (25 g)
Inactive Ingredients
mica bismuth oxychloride brown iron oxide ferric oxide yellow

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-10-03

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings
  • Skin cancer/skin aging alert: spending time in the sun increases your risk of cancer and early aging
  • This product has been shown only to help prevent sunburn, not skin cancer or early aging
  • For External use only
  • Do not use on damage or broken skin
  • When using this product keep out of eyes. Rinse with water to remove
  • Stop use and ask doctor if rash occurs

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

Apply liberally 15 minutes before sun exposure

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 or early skin aging. To decrease this risk, regularly use a 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 sleeve shirts, pants, hats, and sunglasses

Children under 6 month: ask a doctor

Inactive Ingredients

Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide, Zinc Oxide

Description

Drug Facts

Section 42229-5

Drug Facts

Section 51945-4

Active Ingredients

Titanium Dioxide 25%

Zinc Oxide 19%

Questions Or Comments?

Call toll free 1-888-795-4747

Keep Out of Reach of Children

If product is swallowed get medical help or contact a poison control center right away.


Structured Label Content

Warnings
  • Skin cancer/skin aging alert: spending time in the sun increases your risk of cancer and early aging
  • This product has been shown only to help prevent sunburn, not skin cancer or early aging
  • For External use only
  • Do not use on damage or broken skin
  • When using this product keep out of eyes. Rinse with water to remove
  • Stop use and ask doctor if rash occurs

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

Apply liberally 15 minutes before sun exposure

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 or early skin aging. To decrease this risk, regularly use a 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 sleeve shirts, pants, hats, and sunglasses

Children under 6 month: ask a doctor

Inactive Ingredients (Inactive ingredients)

Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide, Zinc Oxide

Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Active Ingredients

Titanium Dioxide 25%

Zinc Oxide 19%

Questions Or Comments? (Questions or Comments?)

Call toll free 1-888-795-4747

Keep Out of Reach of Children (Keep out of reach of children)

If product is swallowed get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)