Label: SOFTLIPS VANILLA- dimethicone, octinoxate, octisalate, oxybenzone ointment

  • NDC Code(s): 10742-3051-1, 10742-3051-2, 10742-3051-3, 10742-3051-9
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Active ingredients

    Dimethicone 2%

    Octinoxate 7.5%

    Octisalate 3%

    Oxybenzone 3%

  • Purpose

    Dimethicone - Skin protectant

    Octinoxate - Sunscreen

    Octisalate - Sunscreen

    Oxybenzone - 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

    ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, flavor, menthol, tocopheryl acetatate [vitamin E]

  • Questions?

    Toll free 1-877-636-2677 MON-FRI 9AM to 5PM (EST) softlips.com

  • Principal Display Panel

    Softlips Vanilla
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    SOFTLIPS  VANILLA
    dimethicone, octinoxate, octisalate, oxybenzone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-3051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    SQUALANE (UNII: GW89575KF9)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    MYRISTYL LACTATE (UNII: 1D822OC34X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MYRISTYL LAURATE (UNII: 58U0NZN2BT)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-3051-11 in 1 BLISTER PACK11/19/1997
    12 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10742-3051-92 in 1 BLISTER PACK11/19/1997
    22 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10742-3051-22 g in 1 TUBE; Type 0: Not a Combination Product11/19/1997
    4NDC:10742-3051-33 in 1 BLISTER PACK03/02/2020
    42 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/19/1997
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-3051)
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