Label: HAWAIIAN TROPIC ISLAND TANNING SUNSCREEN COCOA BUTTER SPF 4- avobenzone,octocrylene lotion

  • NDC Code(s): 63354-771-16, 63354-771-17
  • Packager: Edgewell Personal Care Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2023

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  • Active Ingredients

    Avobenzone 1.0%, Octocrylene 2.0%

  • Purpose

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

    May stain

    some fabrics.

  • Directions

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

  • Inactive ingredients

    Water, Petrolatum, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Sodium Polyacrylate, Chlorphenesin, Fragrance, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Xanthan Gum, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Disodium EDTA, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract

  • Other information

    • protect this product from excessive heat and direct sun

  • Questions or Comments?

    Call 1-800-NO UV RAY, Mon-Fri

  • Principal Display Panel

    HAWAIIAN
    Tropic®
    SUNSCREEN LOTION
    ISLAND TANNING
    ENHANCE TAN & MOISTURIZE
    COCOA BUTTER
    CRUELTY FREE | VEGAN
    SPF 4 UVB
    WATER RESISTANT (80 MINUTES)
    8 FL. OZ (236 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC ISLAND TANNING SUNSCREEN COCOA BUTTER SPF 4 
    avobenzone,octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63354-771
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    GUAVA (UNII: 74O70D6VG0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    PAPAYA (UNII: KU94FIY6JB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    MANGO (UNII: I629I3NR86)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63354-771-16227 g in 1 BOTTLE; Type 0: Not a Combination Product11/13/2019
    2NDC:63354-771-17306 g in 1 BOTTLE; Type 0: Not a Combination Product11/13/201910/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/13/2019
    Labeler - Edgewell Personal Care Brands, LLC (151179769)
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