BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 NEUTRAL DARK 24- zinc oxide powder BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 NEUTRAL DEEP 29- 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 ingredients

Zinc Oxide 20%

Purpose

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
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: ask a doctor
• 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

mica, may contain: titanium dioxide, iron oxides, bismuth oxychloride

Questions or comments?

Call toll free 1-888-795-4747

PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Neutral Dark 24

bareMinerals ®

ORIGINAL FOUNDATION
Broad Spectrum SPF 15

NEUTRAL DARK 24

net wt. 8 g / 0.28 oz.

84240

PRINCIPAL DISPLAY PANEL - 8 g Jar Label - Neutral Deep 29

bareMinerals ®

ORIGINAL FOUNDATION
Broad Spectrum SPF 15

NEUTRAL DEEP 29

net wt. 8 g / 0.28 oz.

84241

INGREDIENTS AND APPEARANCE

BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15  NEUTRAL DARK 24
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1600 mg  in 8 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-026-08	8 g in 1 JAR; Type 0: Not a Combination Product	08/01/2021
2	NDC: 98132-026-02	2 g in 1 JAR; Type 0: Not a Combination Product	08/01/2021
3	NDC: 98132-026-75	0.75 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

BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15  NEUTRAL DEEP 29
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1600 mg  in 8 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-027-08	8 g in 1 JAR; Type 0: Not a Combination Product	08/01/2021
2	NDC: 98132-027-02	2 g in 1 JAR; Type 0: Not a Combination Product	08/01/2021
3	NDC: 98132-027-75	0.75 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)