Label: SOFTLIPS PEARL- octinoxate, octisalate stick

  • NDC Code(s): 10742-8573-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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

    Octinoxate 7.5%

    Octisalate 5%

  • Purpose

    Octinoxate - Sunscreen

    Octisalate - Sunscreen

  • Uses

    • helps prevent sunburn
  • 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

    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

    lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecene copolymer, mineral oil, bis-diglyceryl 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?

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

  • Principal Display Panel

    Softlips Pearl
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    SOFTLIPS PEARL 
    octinoxate, octisalate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8573
    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
    1NDC:10742-8573-11 in 1 BLISTER PACK02/01/2010
    12 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/01/2010
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-8573)
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