Your browser does not support JavaScript! WARM TAN FOUNDATION SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]
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WARM TAN FOUNDATION SPF 15 (titanium dioxide, zinc oxide) powder
[Bare Escentuals Beauty Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:98132-884
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide20 g  in 100 g
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA 
BISMUTH OXYCHLORIDE 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:98132-884-0872 in 1 CASE
18 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/16/2012
Labeler - Bare Escentuals Beauty Inc. (087008363)
Registrant - Ei Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Ei Inc.105803274manufacture(98132-884), label(98132-884), pack(98132-884)

Revised: 2/2013
 
Bare Escentuals Beauty Inc.

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