ELF Super Glossy Lip Shine SPF 15 by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

ELF Super Glossy Lip Shine SPF 15 by

Drug Labeling and Warnings

ELF Super Glossy Lip Shine SPF 15 by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ELF SUPER GLOSSY LIP SHINE SPF 15- oxybenzone, 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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Active Ingredient:

OXYBENZONE: 6.0%

Octyl Methoxycinnamate: 7.5%

Purpose:

Sunscreen

Uses: Help prevent sunburn

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 help prevent sunburn, not skin cancer or skin aging.

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

Directions:

• Apply generously 15 min before sun exposure
• Children under six months of age: ask a doctor
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredient:

Paraffinium Liquidum (Mineral Oil), Polyisobutene, Ethylhexyl Palmitate, Aspartame, Silica, Quartz, Tin Oxide.

May contain:

Mica, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (77891), Red 6 Lake (CI 15851), Red 7 Lake (CI 15850), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410), Red 36 Lake (CI 12085)

ELF SUPER GLOSSY LIP SHINE SPF 15 
oxybenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-105-51	1 in 1 BOX	10/09/2011	12/31/2017
1	NDC: 76354-105-01	10 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/09/2011	12/31/2017

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

Revised: 4/2014

Document Id: 3b5351fa-0d8f-4983-825c-92ffb36854e7

34390-5

Set id: edcec7df-5fed-4ec8-8bc1-32b6508c71c7

Version: 4

Effective Time: 20140408

 

J. A. Cosmetics U.S. INC