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ELF Lip Balm SPF 15 (J. A. Cosmetics U.S. INC)

Available Formats

Dosage Form Package Information Links
CREAM 3 g in 1 TUBE (76354-012-01) Label Information

Complete ELF Lip Balm SPF 15 Information

  • ACTIVE INGREDIENT

    Active Ingredient:

    Benzophenone-3: 5%

    Ethylhexyl Methoxycinnamate: 7.5%


  • PURPOSE

    Purpose:

    Sunscreen


  • INDICATIONS & USAGE

    Uses:

    Helps prevent sunburn


  • WARNINGS

    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

    When Using This Product:

    Keep out of eyes. Rinse with water to remove.


  • ASK DOCTOR

    Stop Use and Ask A Doctor If:

    Rash or irritation develops and lasts


  • KEEP OUT OF REACH OF CHILDREN

    Keep Out Of Reach Of Children:

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


  • DOSAGE & ADMINISTRATION

    Directions:

    Apply liberally as often as needed before sun exposure.

    Reapply as needed or after swimming or towel drying


  • STORAGE AND HANDLING


    Other Information

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

  • INACTIVE INGREDIENT

    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.



  • PRINCIPAL DISPLAY PANEL

    labelabel


  • INGREDIENTS AND APPEARANCE
    ELF LIP BALM SPF 15 
    oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76354-012
    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 (1200000 MW) (UNII: FLT10CH37X)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 39.8 g  in 100 g
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76354-012-01 3 g in 1 TUBE
    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 Business Operations
    Shanghai J. A. Cosmetics Trading CO., LTD. 421280183 manufacture