ELF BEAUTIFULLY BARE FOUNDATION SERUM BROAD SPECTRUM SPF 25 SUNSCREEN LIGHT MEDIUM- zinc oxide cream

ELF Beautifully Bare Foundation Serum Broad Spectrum SPF 25 Sunscreen Light Medium by

Drug Labeling and Warnings

ELF Beautifully Bare Foundation Serum Broad Spectrum SPF 25 Sunscreen Light Medium 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:

Zinc Oxide: 13.8%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Help prevent sunburn

If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

Warning:

For external use only

Do not use on damaged or broken skin

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

If swallowed, get medical help or contact a poison control center immediately

DOSAGE & ADMINISTRATION

Directions:

For sunscreen use:

Apply generously 15 min before sun exposure. Reapply 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

INACTIVE INGREDIENT

Inactive Ingredient:

Cyclopentasiloxane, Water, Dimethicone, Silica, Isododecane, PEG-10 Dimethicone, Acrylates/Dithicone Copolymer, PEG-9 Dimethylsiloxyethyl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Chloride, Quaternium-18, Bentonite, Dimethicone/PEG-10/15 Crosspolymer, Propylene Carbonate, Triethoxycaprylsilane, Talc, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Pentaerythrityl Tetraisosterate, Paraffinum Liquidum (Mineral Oil), Disteardimonium Hectorite, Palmitoyl Tripeptide-1, Punica Granatum Seed Oil, Vitis Vinifera (Grape) Seed Oil, Retinyl Palmitate (Va), Tocopheryl Acetate (Ve), Ascorbyl Palmitate (Vc), Lycium Barbarum Fruit Extract

May contain:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELF BEAUTIFULLY BARE FOUNDATION SERUM BROAD SPECTRUM SPF 25 SUNSCREEN LIGHT MEDIUM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-761
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	9.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISODIUM HEDTA (UNII: KME849MC7A)
SODIUM CHLORATE (UNII: T95DR77GMR)
QUATERNIUM-18 (UNII: O7757NO1VL)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
MINERAL OIL (UNII: T5L8T28FGP)
TALC (UNII: 7SEV7J4R1U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
GRAPE SEED OIL (UNII: 930MLC8XGG)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-761-01	14 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/18/2018

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

Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Facecare Cosmetics Co., Ltd.		545341856	manufacture(76354-761)