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

ELF Flawless Finish Foundation SPF 15 Oil Free by

Drug Labeling and Warnings

ELF Flawless Finish Foundation SPF 15 Oil Free 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 FLAWLESS FINISH FOUNDATION SPF 15 OIL FREE - titanium dioxide cream 
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:

Trolamine Salicylate: 2%

Titanium Dioxide: 5.5%

Purpose:

Sunscreen

Uses:

Help prevent sunburn

Warning:

For external use only

Skin Cancer/Skin Aging Alert:

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

When Using This Product:

Avoid contact with eyes. Rinse with water to remove.

Stop use and ask a doctor if rash ocurs

Keep Out Of Reach Of Children

Directions:

Apply generally 15 min before sun exposure

Children under six months of age: ask a doctor

Reapply every 2 hours

Use a water resistant sunscreen when swimming or sweating

Other Information

Protect the product in this container from excessive heat and direct sunlight
Store at room temperature 15-30 C (59-86F)

Inactive Ingredient:

Water, Cyclonepentasiloxane, Isododecane, Hydrogenated Polyisobutene, Cetyl PEG/PEG-10/1-Dimethicone, Polyglyceryl 4-isostearate, Polymethyl Methacrylate, Sorbitan Sesquiisostearate, Butylene Glycol, Talc, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Phenoxyethanol, Beewax, Potassium Sorbate, Propylene Carbonate, Boron Nitrite, Barium Sulfate,  Caprylyl Glycol

May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)

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ELF FLAWLESS FINISH FOUNDATION SPF 15 OIL FREE 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5 g  in 100 g
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
OCTISALATE (UNII: 4X49Y0596W)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
WATER (UNII: 059QF0KO0R)	38.14 g  in 100 g
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
YELLOW WAX (UNII: 2ZA36H0S2V)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
BORON NITRIDE (UNII: 2U4T60A6YD)
BARIUM SULFATE (UNII: 25BB7EKE2E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
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: 76354-014-01	23 g in 1 BOTTLE; Type 0: Not a Combination Product	10/03/2011	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/03/2011	12/31/2017

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

Revised: 4/2012

Document Id: 6dfa0b87-4a9f-4730-9dbc-2d413c2b9643

34390-5

Set id: 3632efda-a811-4ec7-91ce-fca59f7aa47e

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC