BAREMINERALS WELL-RESTED- titanium dioxide powder

bareMinerals by

Drug Labeling and Warnings

bareMinerals 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 ingredients

Titanium Dioxide 20%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.

Warnings

For external use only

When using this product

• Keep out of Eyes ;
• Rinse with water to remove

Stop use and ask a doctor if

• Rash or irritation developes and lasts.

• Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply evenly before sun exposure as needed.

Other information

• Store at room temperature (59° to 86° F)

Inactive ingredients

Mica, Bismuth Oxychloride, Titanium Dioxide, Iron Oxides.

SPL UNCLASSIFIED SECTION

Distr. By Bare Escentuals Beauty Inc., San Francisco CA 94104 USA

PRINCIPAL DISPLAY PANEL - 2 g Jar Label

bareMinerals Eye Brightener SPF 20

well-rested

2 g / 0.06 Oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS  WELL-RESTED
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
Bismuth Oxychloride (UNII: 4ZR792I587)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-162-01	1.2 g in 1 JAR
2	NDC: 98132-162-02	2 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/05/2011

Labeler - Bare Escentuals Beauty Inc. (087008363)