Label: SOFTLIPS OASIS PEACH MANGO- dimethicone, oxybenzone, octinoxate stick

  • NDC Code(s): 10742-8743-1, 10742-8743-2
  • 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 ingredient

    Dimethicone 2%

    Octinoxate 7.5%

    Oxybenzone 4%

  • Purpose

    Dimethicone - Skin protectant

    Octinoxate - 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, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, ammonium glycyrrhizate, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, ethylhexylglycerin, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, mangifera indica (mango) fruit extract, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, prunus persica (peach) fruit extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [Vitamin C], tocopheryl acetate [Vitamin E]

  • Package/Label Principal Display Panel

    Softlips Oasis Peach Mango
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    SOFTLIPS OASIS PEACH MANGO 
    dimethicone, oxybenzone, octinoxate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8743
    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
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    MANGO (UNII: I629I3NR86)  
    RACEMENTHOL (UNII: YS08XHA860)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    PEACH (UNII: 3OKE88I3QG)  
    SILANETRIOL (UNII: E52D0J3TS5)  
    SILYBUM MARIANUM SEED OIL (UNII: NYY23HEN06)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8743-11 in 1 BLISTER PACK05/01/2019
    14.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10742-8743-24.5 g in 1 TUBE; Type 0: Not a Combination Product07/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/01/2019
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-8743)
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