Label: HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 25- avobenzone,octisalate,octocrylene stick

  • NDC Code(s): 63354-902-61
  • Packager: Edgewell Personal Care Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • Active Ingredients

    Avobenzone 3.0%, Octisalate 5.0%, Octocrylene 10.0%

  • Purpose

    Sunscreen

  • Uses

    helps prevent sunburn

  • Warnings

    For external use only.

    May stain some fabrics

    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.

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

  • Directions

    • apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • reapply after eating or drinking • Children under 6 months: Ask a doctor.

  • Inactive ingredient

    Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, Flavor, Oryza Sativa (RIce) Bran Wax, VP/Eicosene Copolymer, PEG-8, Sodium Saccharin, Tocopheryl Acetate

  • Other information

    protect this product from excessive heat and direct sun

  • Questions / Comments

    1-800-NO UV RAY

  • Primary Display Panel

    TROPICAL flavor

    SPF

    25

    HAWAIIAN

    Tropic (R)

    LIP BALM

    Sunscreen Stick

    Reef Friendly*

    MOISTURIZES

    FOR 12 HOURS

    .14 OZ.

    63354-902-61 Package63354-902-61 Wrap

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 25 
    avobenzone,octisalate,octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    RICE BRAN (UNII: R60QEP13IC)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-902-613.97 g in 1 CYLINDER; Type 0: Not a Combination Product12/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/15/2020
    Labeler - Edgewell Personal Care Brands LLC (151179769)
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