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Medium Foundation SPF 15

Dosage form: powder
Ingredients: Titanium Dioxide 25g in 100g
Labeler: Bare Escentuals Beauty Inc.
NDC Code: 98132-880

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.

BareMineral Original SPF 15 Foundation Medium

Drug Facts

Active IngredientsTitanium Dioxide 25%

PurposeSunscreen

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 IngredientsBismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide

Questions or Comments?Call toll free 1-888-795-4747

MEDIUM FOUNDATION SPF 15 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:98132-880
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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:98132-880-0872 JAR in 1 CASE
18 g in 1 JAR
2NDC:98132-880-1864 JAR in 1 CASE
218 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/FEIOperations
Ei Inc.105803274manufacture(98132-880), label(98132-880)

Revised: 02/2013
Document Id: 179c1df2-9660-4c0d-b9a5-4128d08d2260
Set id: b29403b4-d81e-4f5e-89c8-736a7cfe6573
Version: 4
Effective Time: 20130201
 
Bare Escentuals Beauty Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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