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

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

Drug Details [pdf]

ELF MINERAL 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.

----------

Drug Fact

Active Ingredient:

Zinc Oxide: 15%

Titanium Dioxide: 10%

Purpose:

Sunscreen

Uses:

Help prevent sunburn

Warning:

For external use only

Skin Cancer/Skin Aging Alert:

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

When Using This Product:

Keep out of eyes. Rinse to remove

Stop Use and Ask a Doctor if:

Rash occurs

Keep Out of Reach of Children

Directions:

Apply liberally as needed 15 to 20 minutes before sun exposure

Reapply as needed or after swimming or towel drying

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.

Other Information:

Protect the product in this container from excessive heat and 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 MINERAL FOUNDATION SPF 15 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-007
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: 76354-007-01	2.8 g in 1 BOTTLE; Type 0: Not a Combination Product	10/09/2011	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/09/2011	12/31/2017

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

Revised: 4/2012

Document Id: b6c45221-d29c-45b2-922f-d5b297a48774

34390-5

Set id: 13372192-ac5c-4ea3-9a1d-ab8b0dc0d47b

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC