Label: HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 30- avobenzone,octisalate,octocrylene stick

  • NDC Code(s): 63354-520-61
  • Packager: Edgewell Personal Care Brands LLC
  • Category: HUMAN OTC DRUG LABEL

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.

    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. •Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m., wear long-sleeved shirts, pants, hats, and sunglasses. •Children under 6 months: Ask a doctor

  • Inactive ingredient

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

  • Other Information

    • protect this product from excessive heat and direct sun.

  • Questions / Comments

    1-800-NO UV RAY

  • Principal Display Panel

    TROPICAL flavor
    SPF
    30
    HAWAIIAN TROPIC(R)
    LIP BALM
    Sunscreen Stick
    Water Resistant (80 minutes)
    OXYBENZONE &
    OCTINOXATE FREE
    MOISTURIZES
    FOR 12 HOURS
    (R)
    0.14 OZ (4.25g)

    63354-520-61 Front-Card

    63354-520-61 Back-Card

    63354-520-61 Label

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC LIP BALM SUNSCREEN SPF 30 
    avobenzone,octisalate,octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-520
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CERESIN (UNII: Q1LS2UJO3A)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    RICE BRAN (UNII: R60QEP13IC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-520-614.25 g in 1 CYLINDER; Type 0: Not a Combination Product09/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2021
    Labeler - Edgewell Personal Care Brands LLC (151179769)
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