Drug Fact

ELF LIP BALM SPF 15 - oxybenzone and 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:

Benzophenone-3: 5%

Ethylhexyl 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 to only help prevent sunburn, not skin cancer or skin gaing

When Using This Product:

Keep out of 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:

Paraffinium Liquidum (Mineral Oil), hydrogenated Polyisobutene, Polyethylene Wax, Ceresine Wax, Copernicia Cerifera (Carnauba) Wax, Microcrystalline Wax, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben.

labe label

ELF LIP BALM SPF 15
oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76354-012
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (OXYBENZONE)	OXYBENZONE	5 g in 100 g
OCTINOXATE (OCTINOXATE)	OCTINOXATE	7.5 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYISOBUTYLENE (1200000 MW)
CARNAUBA WAX
MICROCRYSTALLINE WAX
METHYLPARABEN
PROPYLPARABEN
LIGHT MINERAL OIL	39.8 g in 100 g
PEPPERMINT OIL
PHENOXYETHANOL
ETHYLPARABEN
BUTYLPARABEN

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:76354-012-01	3 g in 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2011

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

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

Establishment
Name	Address	ID/FEI	Operations
Shanghai Justking Enterprise Co., Ltd		421267459	manufacture

Revised: 10/2011 J. A. Cosmetics U.S. INC