FAIRLY MEDIUM 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 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-924
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide9.3 g  in 100 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
BROWN IRON OXIDE (UNII: 1N032N7MFO)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:98132-924-0872 in 1 CASE
18 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/12/2012
Labeler - Bare Escentuals Beauty Inc. (087008363)
Registrant - Ei Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Ei Inc.105803274manufacture(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.