ELF Clear SPF 20 Sunscreen Face Primer by J. A. Cosmetics U.S. INC / Hangzhou Facecare Cosmetics Co., Ltd. Drug Fact

ELF Clear SPF 20 Sunscreen Face Primer by

Drug Labeling and Warnings

ELF Clear SPF 20 Sunscreen Face Primer 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 CLEAR SPF 20 SUNSCREEN FACE PRIMER- octinoxate 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.

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Drug Fact

Active Ingredient:

OCTINOXATE: 7.5%

OCTISALATE: 5.0%

OXYBENONE: 5.0%

Purpose:

Sunscreen

Uses:

Help prevent sunburn

Warning:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has only been shown to help prevent sunburn, not skin cancer or ealy skin aging.

For external use only

Do not use on damaged or broken skin

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

If product is swallowed, get medical help or contact a poison control center right away

Directions:

For sunscreen use:

Apply generously 15 min before sun exposure. Reapply every two hours.

Use a water resistant sunscreen if swimming or sweating

Children under six months of age: ask a doctor

Inactive Ingredient:

Dimethicone, Dimethicone Crosspolymer, Ethylhexyl Palmitate, Carotenoids, Bisabolol, Tocopheryl Acetate, Silica Dimethyl Silylate, Phenoxyehtanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben

ELF CLEAR SPF 20 SUNSCREEN FACE PRIMER 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-615
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL PALMITATE (UNII: 2865993309)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-615-01	14 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2015	12/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/10/2015	12/09/2019

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

Revised: 10/2015

Document Id: 53a68219-d920-48f8-b6e6-5e25eecaec8f

34390-5

Set id: 5db4c666-0be1-4aa9-873f-86572efdc83d

Version: 2

Effective Time: 20151017

 

J. A. Cosmetics U.S. INC