Your browser does not support JavaScript! FAIRLY LIGHT FOUNDATION SPF 15 (TITANIUM DIOXIDE) POWDER [BARE ESCENTUALS BEAUTY INC.]
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FAIRLY LIGHT FOUNDATION SPF 15 (titanium dioxide) 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

Titanium Dioxide 25%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

Warnings

For External use only
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask doctor if rash or irritation develops and last
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away

Directions

Apply evenly before sun exposure as needed
Children under 6 month of age: ask a doctor

Inactive Ingredients

Bismuth Oxychloride, Iron Oxides, Mica

Questions or Comments?

Store at room temperature (59F-88F)

Label-8 gLabel-8g continued

Label-18gLabel-8g continued

FAIRLY LIGHT FOUNDATION SPF 15 
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:98132-872
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 DescriptionMarketing Start DateMarketing End Date
1NDC:98132-872-1836 in 1 CASE
118 g in 1 JAR
2NDC:98132-872-08144 in 1 CASE
28 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/06/2010
Labeler - Bare Escentuals Beauty Inc. (087008363)
Registrant - Ei Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Ei Inc.105803274manufacture(98132-872), label(98132-872), pack(98132-872)

Revised: 1/2013
 
Bare Escentuals Beauty Inc.

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