ELF Beautifully Bare Foundation Serum Deep With Goji Berry SPF 25 by J. A. Cosmetics U.S. INC / Hangzhou Facecare Cosmetics Co., Ltd. Drug Fact

ELF Beautifully Bare Foundation Serum Deep With Goji Berry SPF 25 by

Drug Labeling and Warnings

ELF Beautifully Bare Foundation Serum Deep With Goji Berry SPF 25 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 BEAUTIFULLY BARE FOUNDATION SERUM DEEP WITH GOJI BERRY SPF 25- 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.

----------

Drug Fact

Active Ingredient:

Titanium Dioxide: 8.5%

Octinoxate: 7.5%

Octocrylene: 4.0%

Octisalate: 2.0%

Purpose:

Sunscreen

Uses:

Helps 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:

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:

Water, Cyclopentasiloxane, Dimethicone, Isododecane, Phenyl Trimethicone, Silica, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Talc, Cetyl PEG/PEG-10/1 Dimethicone, Sodium Chloride, Acrylates/Dimethicone Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone/PEG-10/15 Crosspolymer, Disteardimonium Hectorite, Propylene Carbonate, Disodium EDTA Alumina, Pentaerythrityl Tetraisostearate, Paraffinum Liguidum (mineral Oil), Palmitoyl Peptide-1, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Retinyl Palmitate (VA), Tocopheryl Acetate (VE), Bisabolol, Ascorbyl Palmitate (VC), Lycium Chinese Fruit Extract, Butylene Glycol, Triethoxycaprylylsilane, Phenoxyethanol, Caprylyl Glycol

May contain:

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

image description

second label

image description

ELF BEAUTIFULLY BARE FOUNDATION SERUM DEEP WITH GOJI BERRY SPF 25 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 76354-621
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.0 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
MINERAL OIL (UNII: T5L8T28FGP)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
VITAMIN A (UNII: 81G40H8B0T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
.BETA.-BISABOLOL (UNII: LP618AV2EA)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 76354-621-0114 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/201712/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/04/201612/02/2019
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 5/2017
 
J. A. Cosmetics U.S. INC