ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Caramel by J. A. Cosmetics U.S. INC / Hangzhou Facecare Cosmetics Co., Ltd. Drug Fact

ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Caramel by

Drug Labeling and Warnings

ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Caramel by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Hangzhou Facecare Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF OIL FREE FLAWLESS FINISH SPF 15 SUNSCREEN FOUNDATION CARAMEL- octisalate 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:

Octisalate: 2.0%

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 your risk of skin cancer or early skin aging. This product has been shown to only protect you from sunburn, not skin cancer or sking 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:

For sunscreen use:

Apply generously 15 min before sun exposure.

Children under six months of age: ask a doctor.

Reapply at least every two hours.

Use a water resistant sunscreen if swimming or sweating

Sun Protection Measures:

Spending time in sun increases your risk of skin cancer or early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including

• Limit time in the sun, especially from 10 am to 2 pm
• Wear long sleeved shirts, pants, hats, and sunglasses.
• Children under six months of age: ask a doctor

Other Information:

Protect this product in the container from excessive heat and direct sun

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

Inactive Ingredient:

Water, Dimethicone, Glycerin, Isododecane, Dimethicone/VinylDimethicone Crosspolymer, Cyclomethicone, Propylene Glycol, CETYL PEG/PPG-10/1 DIMETHICONE, Cyclopentasiloxane, Sorbitan Sesquioleate, Silica, Polymethyl Methacrylate, Talc, Synthetic Beewax, Magnesium Sulfate, Silica Dimethyl Silylate, Boron Nitride, Magnesium Stearate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Bentonite, Fragrance

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499)

ELF OIL FREE FLAWLESS FINISH SPF 15 SUNSCREEN FOUNDATION CARAMEL 
octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-628
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.0 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CYCLOMETHICONE (UNII: NMQ347994Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MAGNESIUM STEARATE (UNII: 70097M6I30)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
MINERAL OIL (UNII: T5L8T28FGP)
TALC (UNII: 7SEV7J4R1U)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-628-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/29/2015	11/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/29/2015	11/09/2018

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

Revised: 1/2016

Document Id: b097d6ae-ce08-46eb-b88e-3be709e3e730

34390-5

Set id: eee54da0-6397-46b0-87e6-c76bde9d11f6

Version: 2

Effective Time: 20160119

 

J. A. Cosmetics U.S. INC