FAIRLY LIGHT FOUNDATION SPF 15- titanium dioxide powder

Fairly Light Foundation SPF 15 by

Drug Labeling and Warnings

Fairly Light Foundation SPF 15 by is a Otc medication manufactured, distributed, or labeled by Bare Escentuals Beauty Inc., Ei Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAIRLY LIGHT FOUNDATION SPF 15 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 98132-872
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 98132-872-18	36 in 1 CASE
1		18 g in 1 JAR
2	NDC: 98132-872-08	144 in 1 CASE
2		8 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/06/2010

Labeler - Bare Escentuals Beauty Inc. (087008363)

Registrant - Ei Inc. (105803274)

Establishment
Name	Address	ID/FEI	Business Operations
Ei Inc.		105803274	manufacture(98132-872) , label(98132-872) , pack(98132-872)