Label: SOFTLIPS PEARL PLUS VANILLA- dimethicone, octinoxate, octisalate, oxybenzone kit

  • NDC Code(s): 10742-7011-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Softlips Pearl

    Drug Facts

  • Active ingredient

    Octinoxate 7.5%

    Octisalate 5%

  • Purpose

    Octinoxate – Sunscreen

    Octisalate - Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Agent 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.

  • Dosage and Administration

    • 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

    lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecane copolymer, mineral oil, bis-diglycerl polyacyladipate-2, oleyl alcohol, copernicia cerifera (carnauba) wax, ricinus communis (castor) seed oil, cetyl lactate, polyethylene, paraffin, ammonium glycyrrhizate, BHT, flavor, magnesium stearate, menthol, tocopheryl acetate [vitamin E], bismuth oxychloride, carmine, mica, titanium dioxide

  • Questions or comments?

    1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

    Softlips.com

  • SPL UNCLASSIFIED SECTION

    Softlips Vanilla

    Drug Facts

  • Active Ingredient

    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 Agent 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.

  • Dosage and Administration

    • 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 acetate [vitamin E]

  • Questions or comments?

    1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

    Softlips.com

  • Principal Display Panel

    Front Blistercard
  • Principal Display Panel

    Back Blistercard
  • INGREDIENTS AND APPEARANCE
    SOFTLIPS  PEARL PLUS VANILLA
    dimethicone, octinoxate, octisalate, oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-7011
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-7011-11 in 1 PACKAGE; Type 0: Not a Combination Product01/02/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CYLINDER 1 g
    Part 21 CYLINDER 1 g
    Part 1 of 2
    SOFTLIPS  PEARL
    octinoxate, octisalate stick
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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 OIL (UNII: OVV5IIJ58F)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    CERESIN (UNII: Q1LS2UJO3A)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETYL LACTATE (UNII: A7EVH2RK4O)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/01/2010
    Part 2 of 2
    SOFTLIPS  VANILLA
    dimethicone, octinoxate, octisalate, oxybenzone stick
    Product Information
    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
    12 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/19/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/02/2017
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-7011)
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