MEDIUM FOUNDATION SPF 15 - titanium dioxide powder
Bare Escentuals Beauty Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Titanium Dioxide 25%

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

Skin cancer/skin aging alert: spending time in the sun increases your risk of cancer and early aging
This product has been shown only to help prevent sunburn, not skin cancer or early aging
For External use only
Do not use on damage or broken skin
When using this product keep out of eyes. Rinse with water to remove
Stop use and ask 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

Apply liberally 15 minutes before sun exposure
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 or early skin aging. To decrease this risk, regularly use a 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
Children under 6 month: ask a doctor

Inactive Ingredients

Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide

Questions or Comments?

Call toll free 1-888-795-4747

MEDIUM FOUNDATION SPF 15
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:98132-880
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (Titanium Dioxide)	Titanium Dioxide	25 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA
BISMUTH OXYCHLORIDE
BROWN IRON OXIDE
FERRIC OXIDE YELLOW

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:98132-880-08	72 JAR ( JAR) in 1 CASE	contains a JAR
1		8 g in 1 JAR	This package is contained within the CASE (98132-880-08)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/16/2012

Labeler - Bare Escentuals Beauty Inc. (087008363)

Registrant - Ei Inc. (105803274)

Establishment
Name	Address	ID/FEI	Operations
Ei Inc.		105803274	manufacture, label, pack

Revised: 06/2012 Bare Escentuals Beauty Inc.