Label: INTENSE THERAPY LIP BALM BASIL LEMON- sunscreen skin protectant lip balm ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated July 17, 2019

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  • Warning

    Stop use and ask doctor if rash occurs

    Children under 6 months: Ask a doctor

  • Directions

    Apply liberally and reapply every 2 hours or after eating, drinking, swimming or wiping lips.

  • Active Ingredients

    Avobenzone 3.0% Sunscreen

    Octinoxate 7.5% Sunscreen

    Petrolatum 40.2% Skin Protectant

  • Uses

    Helps prevent sunburn and chapped lips.

  • Keep out of Reach of Children

    Keep out of Reach of Children

  • Inactive Ingredients

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

  • Questions

    www.getjackblack.com

    1-877-766-3388

  • Label

    Basil Lemon Lip Balm Artwork.jpg

  • INGREDIENTS AND APPEARANCE
    INTENSE THERAPY LIP BALM BASIL LEMON 
    sunscreen skin protectant lip balm ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66738-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 g  in 1000 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 g  in 1000 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM402 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    CERESIN (UNII: Q1LS2UJO3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (Basil Lemon) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66738-045-257 g in 1 TUBE; Type 1: Convenience Kit of Co-Package06/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/08/2018
    Labeler - Jack Black, LLC (847024036)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(66738-045)
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