Label: SOFTLIPS WATERMELON- dimethicone, octinoxate, octisalate, oxybenzone stick

  • NDC Code(s): 10742-8476-1, 10742-8476-2, 10742-8476-3
  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Dimethicone 2%

    Octinoxate 7.5%

    Octisalate 3%

    Oxybenzone 3%

  • Purpose

    Dimethicone - Skin protectant

    Octinoxate - Sunscreen

    Octisalate - Sunscreen

    Oxybenzone - Sunscreen

  • Keep Out of Reach of Children

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

  • Uses

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

    Skin Cancer/Skin Aging Alert: Spending time in the sun increased 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
  • 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
  • Inactive ingredients

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

  • Package/Label Principal Display Panel

    Softlips Watermelon
  • Principal Display Panel

    Drug Facts
  • INGREDIENTS AND APPEARANCE
    SOFTLIPS   WATERMELON
    dimethicone, octinoxate, octisalate, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8476
    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 ug  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 ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8476-11 in 1 BLISTER PACK04/16/2012
    12 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10742-8476-22 in 1 BLISTER PACK12/01/2016
    22 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10742-8476-33 in 1 BLISTER PACK04/06/2020
    32 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/16/2012
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-8476) , label(10742-8476)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!