FAIRLY MEDIUM FOUNDATION SPF 15- zinc oxide and 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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BareMineral Original SPF 15 Foundation Fairly Medium

Drug Facts

Active Ingredients

Zinc Oxide 9.3%
Titanium Dioxide 25%

Purpose

Sunscreen
Sunscreen

Uses

Warnings

For External use only

Directions

  • 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 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

Inactive Ingredients

Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide

Questions or Comments?

Call toll free 1-888-795-4747

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FAIRLY MEDIUM FOUNDATION SPF 15 
titanium dioxide, zinc oxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:98132-924
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 9.3 g  in 100 g
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)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:98132-924-08 72 in 1 CASE
1 8 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/12/2012
Labeler - Bare Escentuals Beauty Inc. (087008363)
Registrant - Ei Inc. (105803274)
Establishment
Name Address ID/FEI Business Operations
Ei Inc. 105803274 manufacture(98132-924) , label(98132-924)

Revised: 2/2013
Document Id: 822c0ccb-3a77-436d-88c6-dacc56749a95
Set id: ff947b5d-b6ac-449d-966c-cc9b7b4c1175
Version: 2
Effective Time: 20130204
 
Bare Escentuals Beauty Inc.