ELF Flawless Finish Foundation Oil Free SPF 15 Sunscreen Alabaster by J. A. Cosmetics U.S. INC / Hangzhou Facecare Cosmetics Co., Ltd. Drug Fact

ELF Flawless Finish Foundation Oil Free SPF 15 Sunscreen Alabaster by

Drug Labeling and Warnings

ELF Flawless Finish Foundation Oil Free SPF 15 Sunscreen Alabaster 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 FLAWLESS FINISH FOUNDATION OIL FREE SPF 15 SUNSCREEN ALABASTER- 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:

Titanium Dioxide: 4.45%

Octinoxate: 4.0%

Octisalate: 3.0%

Purpose:

Sunscreen

Uses:

Helps prevent sunburn

Warning:

For external use only

Skin Cancer/ Skin Aging Alert:

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

For suncreen use:

Apply generally 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 15C-30C (59F-86F)

Inactive Ingredient:

Water (Aqua), Glycerin, Isododecane, Dimethicone, Cyclopentasiloxane, Propylene Glycol, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Tridecyl Trimellitate, Sorbitan Sesquioleate, Cyclohexasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Polymethyl Methacrylate, Boron Nitride, Magnesium Sulfate, Magnesium Stearate, PEG/PPG-15/15 Dimethicone, Disteardimonium Hectorite, Silica Dimethyl Silylate, Aluminum Hydroxide, Triethoxycaprylylsilane, Silica, Alumina, Fragrance (Parfum), Phenoxyethanol, Caprylyl Glycol, EthylhexylglycerinMA

May contain:

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

ELF FLAWLESS FINISH FOUNDATION OIL FREE SPF 15 SUNSCREEN ALABASTER 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-632
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.45 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.0 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.0 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 (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)
BORON NITRIDE (UNII: 2U4T60A6YD)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
PEG/PPG-15/15 DIMETHICONE (UNII: 184IZ28A2G)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-632-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/19/2015	11/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/19/2015	11/09/2018

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

Revised: 8/2017

Document Id: 5e1c8b20-e252-4243-be5e-0e4f238848fa

34390-5

Set id: c877197c-dc75-4488-bc69-4fa566016e98

Version: 2

Effective Time: 20170811

 

J. A. Cosmetics U.S. INC