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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Drug Facts

Active Ingredients

Zinc Oxide 9.3%
Titanium Dioxide 25%

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

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
  • 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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide9.3 g  in 100 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA 
BISMUTH OXYCHLORIDE 
BROWN IRON OXIDE 
FERRIC OXIDE YELLOW 
Packaging
#Item CodePackage Description
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: 01/2013
Document Id: eba0b70d-6eee-4997-a344-405600d1afbe
Set id: ff947b5d-b6ac-449d-966c-cc9b7b4c1175
Version: 1
Effective Time: 20130131
 
Bare Escentuals Beauty Inc.