ELF Conditioning Lip Balm SPF 15

Dosage form: cream
Ingredients: OXYBENZONE 3g in 100g, OCTINOXATE 7.5g in 100g
Labeler: J. A. Cosmetics U.S. INC
NDC Code: 76354-011

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (OXYBENZONE) OXYBENZONE3 g  in 100 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYISOBUTYLENE (1100000 MW) 
ALPHA-TOCOPHEROL 
MICROCRYSTALLINE WAX 
METHYLPARABEN 
PROPYLPARABEN 
MINERAL OIL18.7 g  in 100 g
STANNIC OXIDE 
MICA 
CERESIN 
ETHYLHEXYL PALMITATE 
VITAMIN A PALMITATE 
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 
Packaging
#Item CodePackage Description
1NDC:76354-011-017.5 g in 1 TUBE
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 J. A. Cosmetics Trading CO., LTD.421280183manufacture

Revised: 04/2012
 
J. A. Cosmetics U.S. INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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