Label: HAWAIIAN TROPIC- avobenzone, octocrylene, oxybenzone stick

  • NDC Code(s): 63354-300-63
  • Packager: Edgewell Personal Care LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 20, 2017

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

  • Active Ingredients

    Avobenzone 1%, Octocrylene 10%, Oxybenzone 6%

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  • Purpose

    Sunscreen

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  • Uses

    helps prevent sunburn

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  • Warnings

    For external use only

    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.

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  • Do not use

    on damaged or broken skin

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  • When using this product

    keep out of eyes. Rinse with water to remove.

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  • Stop use and ask a doctor

    if rash occurs

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  • 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

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  • 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

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  • Inactive Ingredients

    Ozokerite, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Diisobutyl Adipate, Cetyl Alcohol, Cyclopentasiloxane, Theobroma Cacao (Cocoa)Seed Butter, Adipic Acid/Diglycol Crosspolymer, Dimethicone, Flavor, Isostearyl Linoleate, cyclohexasiloxane, PEG-8, Silica, Sodium Saccharin, Propylparaben, BHT, Mineral Oil, PEG-8 Dimethicone, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Octyldodecanol, Retinyl Palmitate, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica.

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  • Other Information

    protect this product from excessive heat and direct sun

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  • Questions/Comments?

    1-800 NO UV RAY

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  • PRINCIPAL DISPLAY PANEL

    TRPOICAL Flavor

    HAWAIIAN

    Tropic

    LIP BALM

    Sunscreen Stick

    Water Resistant (80 minutes)

    SPF

    45

    6335430063

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  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC 
    avobenzone, octocrylene, oxybenzone stick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-300
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)  
    SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COLOCASIA ESCULENTA ROOT (UNII: H7B71Q0G0D)  
    MANGIFERA INDICA WHOLE (UNII: U34MFR958F)  
    PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)  
    PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    ISOSTEARYL LINOLEATE (UNII: 4778M3HR0N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PAPAYA (UNII: KU94FIY6JB)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63354-300-63 4 g in 1 BLISTER PACK; Type 0: Not a Combination Product 01/11/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/11/2012
    Labeler - Edgewell Personal Care LLC (021718141)
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