BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 TAN 19- titanium dioxide and zinc oxide powder

bareMinerals Original Foundation Broad Spectrum SPF 15 by

Drug Labeling and Warnings

bareMinerals Original Foundation Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Orveon Global US LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient(s)	Purpose
Titanium dioxide 9%	Sunscreen
Zinc oxide 22%	Sunscreen

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

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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?

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PRINCIPAL DISPLAY PANEL - 8 g Jar Label

bareMinerals ®

ORIGINAL FOUNDATION
Broad Spectrum SPF 15

TAN 19

net wt. 8 g / 0.28 oz.

61275

INGREDIENTS AND APPEARANCE

BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15  TAN 19
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	720 mg  in 8 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1760 mg  in 8 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-012-08	8 g in 1 JAR; Type 0: Not a Combination Product	08/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/01/2021

Labeler - Orveon Global US LLC (118344494)