Label: MENTHOLATUM MEDICATED LIP BALM ORIGINAL- dimethicone, octinoxate, octisalate ointment

  • NDC Code(s): 10742-8865-1, 10742-8865-3
  • Packager: The Mentholatum Company
  • 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 February 7, 2023

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  • Active ingredients

    Dimethicone 1%

    Octinoxate 7.5%

    Octisalate 5%

  • Purpose

    Dimethicone - Skin protectant

    Octinoxate - Sunscreen

    Octisalate - Sunscreen

  • Uses

    • helps prevent sunburn
    • temporarily protects chapped or cracked lips
  • Warnings

    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 prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use

    on damaged or broken skin

    When using this product

    Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash occurs
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: ask a doctor

    Other information

    • protect this product from excessive heat and direct sun
  • Inactive ingredients

    fragrance, lanolin, menthol, mineral oil, ozokerite, petrolatum

  • Questions?

    Toll free 1-877-636-2677

    MON-FRI 9 AM to 5 PM (EST)

  • Principal Display Panel

    Mentholatum Medicated Lip Balm Original
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM MEDICATED LIP BALM   ORIGINAL
    dimethicone, octinoxate, octisalate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8865
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8865-11 in 1 BLISTER PACK08/01/2016
    14.2 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10742-8865-33 in 1 BLISTER PACK10/01/2018
    24.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2016
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-8865)
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