ELF Conditioning Lip Balm SPF 15 by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD. Drug Fact

ELF Conditioning Lip Balm SPF 15 by

Drug Labeling and Warnings

ELF Conditioning Lip Balm 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 CONDITIONING LIP BALM SPF 15 - oxybenzone 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:

Benzophenone-3: 3%

Octyl methoxycinnamate: 7.5%

Purpose:

Sunscreen

Uses:

Applying on lip area helps prevent sunburn

Warning:

For external use only

Skin Cancer/Skin Aging Alert:

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

When Using This Product:

Avoid contact with eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If:

Rash or irritation develops and lasts

Keep Out Of Reach Of Children:

If swallowed get medical help or contact a Poison Control Center immediately

Directions:

Apply liberally as often as needed before sun exposure.

Reapply as needed or after swimming or towel drying

Other Information

Store at room temperature 20-25 C (77-86F)

Inactive Ingredient:

Polyisobutene, Mineral Oil, Octyl Palmitate, Polyethylene Wax, Ceresine Wax,  Microcrystalline Wax, Ozokerite, Mica, Tin Oxide, Methylparaben, Butylparaben, Tocopherol (VE), Retinyl Palmitate (VA). May Contain: Iron Oxide (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742), Red No. 27 Lake (CI 45410), Red No. 7 Lake (CI 15850), Red No. 6 Lake (CI 15850), Blue No. 1 Lake (CI 42090), Yellow No. 5 Lake (CI 19140), Yellow No. 6 Lake (CI 15985).

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ELF CONDITIONING LIP BALM SPF 15 
oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 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)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MINERAL OIL (UNII: T5L8T28FGP)	18.7 g  in 100 g
STANNIC OXIDE (UNII: KM7N50LOS6)
MICA (UNII: V8A1AW0880)
CERESIN (UNII: Q1LS2UJO3A)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C RED NO. 6 (UNII: 481744AI4O)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-011-01	7.5 g in 1 TUBE; Type 0: Not a Combination Product	10/08/2011	12/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/08/2011	12/31/2017

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

Revised: 4/2012

Document Id: 17d3504b-72ff-4a69-afac-d15015d6b56f

34390-5

Set id: 4e556bd9-3605-40c8-a9c3-f03a42f64494

Version: 3

Effective Time: 20120418

 

J. A. Cosmetics U.S. INC