ELF BEAUTIFULLY BARE FOUNDATION SERUM DARK DEEP WITH GOJI BERRY SPF 25- titanium dioxide cream

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

Drug Labeling and Warnings

ELF Beautifully Bare Foundation Serum Dark 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]

ACTIVE INGREDIENT

Active Ingredient:

Titanium Dioxide: 8.5%

Octinoxate: 7.5%

Octocrylene: 4.0%

Octisalate: 2.0%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Helps prevent sunburn

WARNINGS

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

When using this product:

Keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop Use and Ask a Doctor if:

Rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children

DOSAGE & ADMINISTRATION

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

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)

PRINCIPAL DISPLAY PANEL

second label

INGREDIENTS AND APPEARANCE

ELF BEAUTIFULLY BARE FOUNDATION SERUM DARK DEEP WITH GOJI BERRY SPF 25 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-620
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.0 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-620-01	14 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2017	01/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/04/2016	01/12/2021

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