ELF OIL FREE FLAWLESS FINISH SPF 15 SUNSCREEN FOUNDATION BUFF- octisalate cream 
e.l.f. Cosmetics, Inc

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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 BUFF 
octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-627
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-627-0120 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/04/2016
Labeler - e.l.f. Cosmetics, Inc (093902816)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Ayan Biotech Co., Ltd.544377996manufacture(76354-627)

Revised: 11/2023
Document Id: 09889827-2493-3c32-e063-6394a90a2d4b
Set id: 55b07535-7fba-486b-a84e-628c00f7f9a8
Version: 4
Effective Time: 20231106
 
e.l.f. Cosmetics, Inc