BAREMINERALS FAUX TAN FAUX TAN- titanium dioxide powder

BareMinerals Faux Tan by

Drug Labeling and Warnings

BareMinerals Faux Tan 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 6%

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 develops 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

Inactive Ingredients

Mica, Bismuth Oxychloride, Iron Oxides, Silica, Titanium Dioxide, Ultramarines, Carmine.

Other Information

• Store at room temperature (59°-88°F)
• Adverse Event Reporting: 71 Stevenson St., 22 Fl., SF, CA 94105. Attn: OTC

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 4 g Jar Label

bareMinerals
SPF 15 All-Over Face Color

faux tan SPF 15

4 g / 0.14 Oz.

INGREDIENTS AND APPEARANCE

BAREMINERALS FAUX TAN  FAUX TAN
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-158
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
Bismuth Oxychloride (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Ultramarine Blue (UNII: I39WR998BI)
Cochineal (UNII: TZ8Z31B35M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-158-03	6 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)