ELF LIP BALM SPF 15 COLOR  - 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%

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).


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ELF LIP BALM SPF 15 COLOR 
oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (OXYBENZONE) OXYBENZONE5 g  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYISOBUTYLENE (1100000 MW) 
ALPHA-TOCOPHEROL 
MICROCRYSTALLINE WAX 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
MINERAL OIL18.7 g  in 100 g
CERESIN 
MEDIUM-CHAIN TRIGLYCERIDES 
CARNAUBA WAX 
D&C RED NO. 27 
D&C RED NO. 7 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
D&C RED NO. 6 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:76354-013-012.1 g in 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/08/2011

Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIOperations
Shanghai Justking Enterprise Co. Ltd.421267459manufacture

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