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

ELF Lip Balm SPF 15 Color by

Drug Labeling and Warnings

ELF Lip Balm SPF 15 Color 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 LIP BALM SPF 15 COLOR - 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: 5%

Octyl methoxycinnamate: 7.5%

Purpose:

Sunscreen

Uses:

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

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, , Ceresine Wax,  Caprylic/Capric Triglyceride, Cera Carnauba (Carnauba) Wax, Microcrystalline Wax, Phenoxyethanol,  Ethylhexylglycerin, Tocopherol (VE). 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).

lab

ELF LIP BALM SPF 15 COLOR 
oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 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)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MINERAL OIL (UNII: T5L8T28FGP)	18.7 g  in 100 g
CERESIN (UNII: Q1LS2UJO3A)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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: 76354-013-01	2.1 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: 150309a1-2d6b-4f9d-9f61-ef621e35d7c0

34390-5

Set id: a5781527-d69a-4e43-9070-f00016be7cb3

Version: 3

Effective Time: 20120418