WARM TAN FOUNDATION SPF 15 - titanium dioxide, zinc oxide 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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BareMineral Original SPF 15 Foundation Warm Tan

Drug Facts

Active Ingredients

Zinc Oxide 20%
Titanium Dioxide 7%

Purpose

Sunscreen
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

Questions or Comments?

Call toll free 1-888-795-4747

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WARM TAN FOUNDATION SPF 15
titanium dioxide, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:98132-884
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g in 100 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

#	Item Code	Package Description
Packaging
1	NDC:98132-884-08	72 in 1 CASE
1		8 g in 1 JAR

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

Labeler - Bare Escentuals Beauty Inc. (087008363)

Registrant - Ei Inc. (105803274)

Name	Address	ID/FEI	Business Operations
Establishment
Ei Inc.		105803274	manufacture(98132-884) , label(98132-884) , pack(98132-884)