ELF MINERAL FOUNDATION SPF 15- titanium dioxide powder

ELF Mineral Foundation SPF 15 by

Drug Labeling and Warnings

ELF Mineral Foundation SPF 15 by is a Otc medication manufactured, distributed, or labeled by Hangzhou Facecare Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Zinc Oxide: 15%

Titanium Dioxide: 10%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Our weightless Mineral Foundation will help get you on your way to healthier looking skin. The powder blends naturally into the skin and is so light that it works with your skin color to create a perfect color match.  All of our mineral foundation contain sun protection factor (spf) 15 to help combat against aging and are 100% meineral based.

WARNINGS

Warning:

For external use only

WHEN USING

When Using This Product:

Avoid contact with eyes. If contact occurs, rinse thoroughly with water

ASK DOCTOR

Stop Use and Ask a Doctor if:

Rash or irritation develops and lasts

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children:

If swallowed get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Directions:

Shake the Nature Mineral Foundation SPF 15 back and forth to get excess powder loose onto the tray. Gently glide over the powder with the Total Face Brush to grab the powder, bring your brush to the cap to work in the powder to the brush, then tap off any excess. Apply to the areas of the face that need coverage by working into the skin in a circular motion.

STORAGE AND HANDLING

Other Imformation:

Store at room temperature 15-30C (59-86F)

INACTIVE INGREDIENT

Inactive Ingredient:

Mica, Fragrance, Bismuth Oxychloride, Tocopheryl Acetate, Boron Nitride

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742), Ultramarine Blue (CI 77007)

PRINCIPAL DISPLAY PANEL

label

INGREDIENTS AND APPEARANCE

ELF MINERAL FOUNDATION SPF 15 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52664-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52664-004-01	2.8 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2010

Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Facecare Cosmetics Co., Ltd.		545341856	manufacture