ELF Personal Blend Foundation SPF 15 by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

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 J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF PERSONAL BLEND FOUNDATION SPF 15 - titanium dioxide powder 
J. A. Cosmetics U.S. INC

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.

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Drug Fact

Active Ingredient:

Zinc Oxide: 15%

Titanium Dioxide: 10%

Purpose:

Sunscreen

Uses:

Help prevent Sunburn

Warning:

External use only

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer/early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or skin aging.

When Using This Product:

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask a Doctor if rash occurs

Keep Out of Reach of Children

Directions:

Apply liberally as needed 15-20 min before sun exposure.

Reapply as needed or after swimming or towel drying.

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.

Other Information:

Protect this product in this container from excessive heat or direct sun.

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)

label

ELF PERSONAL BLEND FOUNDATION SPF 15 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-009
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: 76354-009-01	8 g in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2011	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2011	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 4/2012

Document Id: 1458b822-ca46-4e5e-aa56-98a13f855d34

34390-5

Set id: 18640ed0-27ba-43aa-9f1e-37a9293843ac

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC