ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM- octinoxate cream

ELF Broad Spectrum SPF 20 Sunscreen Buff BB Cream by

Drug Labeling and Warnings

ELF Broad Spectrum SPF 20 Sunscreen Buff BB Cream 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:

OCTINOXATE: 7.5%

OCTISALATE: 5.0%

OXYBENONE: 4.0%

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

INACTIVE INGREDIENT

Inactive Ingredient:

Water, Glycerin, Propylene Glycol, C12-15 Akyl Benzoate, Titanium Dioxide, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Sorbitan Olivate, Polymethyl Methacrylate, Sodium Chloride, Quaternium-18, Bentonite, Triethoxycaprylsilane, Dimethicone, Zinc Stereate, Talc, VP/Hexadecene Copolymer, Bisabolol, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Aloe Barbadensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Mica, Silica, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone, Fragrance

May contain:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ELF BROAD SPECTRUM SPF 20 SUNSCREEN BUFF BB CREAM 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM CHLORATE (UNII: T95DR77GMR)
QUATERNIUM-18 (UNII: O7757NO1VL)
BENTONITE (UNII: A3N5ZCN45C)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ZINC STEARATE (UNII: H92E6QA4FV)
TALC (UNII: 7SEV7J4R1U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ)
JOJOBA OIL (UNII: 724GKU717M)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-610-01	28.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/10/2015

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(76354-610)