BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 NEUTRAL DARK- zinc oxide powder BAREMINERALS ORIGINAL FOUNDATION BROAD SPECTRUM SPF 15 NEUTRAL DEEP- 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 Bare Escentuals Beauty, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient(s)

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 product is 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-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

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

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-795-4747

SPL UNCLASSIFIED SECTION

Dist. by Bare Escentuals Beauty, Inc., San Francisco, CA 94105 USA

PRINCIPAL DISPLAY PANEL - 18 g Jar Label - Neutral Dark

bareMinerals ORIGINAL Foundation
Broad Spectrum SPF 15

net wt 18 g / 0.6 oz.

Dist. by Bare Escentuals Beauty, Inc., San Francisco, CA 94105, USA
London W1F 8ZU Made in USA

PRINCIPAL DISPLAY PANEL - 18 g Jar Label - Neutral Deep

bareMinerals ORIGINAL Foundation
Broad Spectrum SPF 15

net wt 18 g / 0.6 oz.

Dist. by Bare Escentuals Beauty, Inc., San Francisco, CA 94105, USA
London W1F 8ZU Made in USA

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-907
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g  in 100 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: 98132-907-18	18 g in 1 JAR; Type 0: Not a Combination Product	02/01/2017
2	NDC: 98132-907-08	8 g in 1 JAR; Type 0: Not a Combination Product	02/01/2017
3	NDC: 98132-907-02	2 g in 1 JAR; Type 0: Not a Combination Product	02/01/2017
4	NDC: 98132-907-75	0.75 g in 1 JAR; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2017

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-908
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g  in 100 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: 98132-908-18	18 g in 1 JAR; Type 0: Not a Combination Product	02/01/2017
2	NDC: 98132-908-08	8 g in 1 JAR; Type 0: Not a Combination Product	02/01/2017
3	NDC: 98132-908-02	2 g in 1 JAR; Type 0: Not a Combination Product	02/01/2017
4	NDC: 98132-908-75	0.75 g in 1 JAR; Type 0: Not a Combination Product	02/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2017

Labeler - Bare Escentuals Beauty, Inc. (087008363)