ELF OIL FREE FLAWLESS FINISH SPF 15 SUNSCREEN FOUNDATION PORCELAIN- 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

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)

label

ELF OIL FREE FLAWLESS FINISH SPF 15 SUNSCREEN FOUNDATION PORCELAIN 
octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-625
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ISODODECANE (UNII: A8289P68Y2)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
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 ANHYDROUS (UNII: ML30MJ2U7I)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-625-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/30/2019
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Facecare Cosmetics Co., Ltd.545341856manufacture(76354-625)

Revised: 12/2020
Document Id: b61ff44f-72e0-60f1-e053-2995a90aa3d0
Set id: cdf9ad65-cc47-4087-b3ec-2e21bc2858d2
Version: 4
Effective Time: 20201210
 
J. A. Cosmetics U.S. INC