Label: ELF OIL FREE FLAWLESS FINISH SPF 15 SUNSCREEN FOUNDATION BUFF- octisalate cream
- NDC Code(s): 76354-627-01
- Packager: e.l.f. Cosmetics, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- 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
Other Information:
Protect this product in the container from excessive heat and direct sun
Store at room temperature 15-30 C (59-86F)
- 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
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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
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INGREDIENTS AND APPEARANCE
ELF OIL FREE FLAWLESS FINISH SPF 15 SUNSCREEN FOUNDATION BUFF
octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76354-627 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 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:76354-627-01 20 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/04/2016 Labeler - e.l.f. Cosmetics, Inc (093902816) Establishment Name Address ID/FEI Business Operations Zhejiang Ayan Biotech Co., Ltd. 544377996 manufacture(76354-627)
