ELF OIL FREE FLAWLESS FINISH SPF 15 SUNSCREEN FOUNDATION PORCELAIN- octisalate cream

ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Porcelain by

Drug Labeling and Warnings

ELF Oil free flawless Finish SPF 15 Sunscreen Foundation Porcelain 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]

ACTIVE INGREDIENT

Active Ingredient:

Octisalate: 2.0%

Titanium Dioxide: 5.5%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Help prevent sunburn

WARNINGS

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

When using this product:

Keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop Use and Ask a Doctor if:

Rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

DOSAGE & ADMINISTRATION

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

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-625
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 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
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-625-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/30/2019

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

Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Facecare Cosmetics Co., Ltd.		545341856	manufacture(76354-625)