Label: JACK BLACK INTENSE THERAPY LIP BALM PASSION FRUIT- avobenzone, octinoxate lip balm sunscreen ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2023

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  • Warnings

    Stop use and ask doctor if rash occurs.

  • Keep out of reach of children

    Keep out of reach of children

  • Active Ingredients

    avobenzone   3.0%   sunscreen

    octinoxate   7.5%   sunscreen

    petrolatum   40.2%   skin protectant

  • Uses

    Helps prevent sunburn and chapped lips.

  • Uses

    Helps prevent sunburn and chapped lips.

  • Directions

    Apply liberally 15 minutes before sun exposure. Children under 6 months: ask a doctor.

  • Inactive Ingredients

    theobroma cacao (coca) seed butter, lanolin, beeswax, ozokerite, polyglyceryl-3 beeswax, flavor, butyrospermum parkii (shea) butter, persea gratissima (avocado) oil, C18-38 alkyl hydroxystearol stearate, tocopheryl acetate, cyclopentasiloxane, microcrystalline wax, camellia sinenesis (green tea) leaf extract, cyclohexasiloxane

  • Questions

    www.getjackblack.com

    1-877-766-3388

  • Labeling

    Passion Fruit Artwork

  • INGREDIENTS AND APPEARANCE
    JACK BLACK INTENSE THERAPY LIP BALM PASSION FRUIT 
    avobenzone, octinoxate lip balm sunscreen ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66738-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM402 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CERESIN (UNII: Q1LS2UJO3A)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66738-065-257 g in 1 TUBE; Type 0: Not a Combination Product08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/03/2020
    Labeler - Jack Black, LLC (847024036)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(66738-065)
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