ELF PERSONAL BLEND FOUNDATION SPF 15- titanium dioxide powder

ELF Personal Blend Foundation SPF 15 by

Drug Labeling and Warnings

ELF Personal Blend Foundation SPF 15 by is a Otc medication manufactured, distributed, or labeled by Shanghai Justking Enterprise 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:

Help prevent Sunburn

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:

Move the dial opening to desired color and shake the Personal Blend Foundation SPF 15 back and forth to get excess powder loose onto the tray. Gently glide over the powder with a 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. When not in use, move the dial opening in between two colors so the dial opening is closed.

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 PERSONAL BLEND FOUNDATION SPF 15 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76166-001
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: 76166-001-01	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	05/01/2011

Labeler - Shanghai Justking Enterprise Co. Ltd. (421267459)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Justking Enterprise Co. Ltd.		421267459	manufacture