ELF SPF 20 Sunscreen Face Primer Clear by J. A. Cosmetics U.S. INC / Shanghai Tianle Daily Chemical Factory Drug Fact

ELF SPF 20 Sunscreen Face Primer Clear by

Drug Labeling and Warnings

ELF SPF 20 Sunscreen Face Primer Clear by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai Tianle Daily Chemical Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF SPF 20 SUNSCREEN FACE PRIMER CLEAR- 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: 4.0%

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 SPF 20 SUNSCREEN FACE PRIMER CLEAR 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-715
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: 76354-715-01	14 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/09/2015	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/09/2015	12/31/2018

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

Revised: 8/2015

Document Id: 7e9e9552-fc12-431e-8cb0-7c8fc64114f4

34390-5

Set id: 03b0cb0b-fa58-40a7-8489-2650cdf7cfa7

Version: 2

Effective Time: 20150829

 

J. A. Cosmetics U.S. INC