Home > Drugs A-Z > Drugs A-Z

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

Available Formats

Dosage Form Package Information Links
CREAM 2.1 g in 1 TUBE (76354-013-01) Label Information

Complete ELF Lip Balm SPF 15 Color Information

  • ACTIVE INGREDIENT

    Active Ingredient:

    Benzophenone-3: 5%

    Octyl 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 only to help prevent sunburn, not skin cancer or skin aging.


  • WHEN USING

    When Using This Product:

    Avoid contact with eyes. Rinse with water to remove.


  • ASK DOCTOR

    Stop Use and Ask A Doctor If:

    Rash or irritation develops


  • 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:

    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).



  • PRINCIPAL DISPLAY PANEL

    lablabel


  • INGREDIENTS AND APPEARANCE
    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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/08/2011
    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