Label: HAWAIIAN TROPIC - avobenzone, octocrylene and oxybenzone stick 

  • NDC Code(s): 63354-300-63
  • Packager: Energizer Personal Care LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

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  • Directions

    • apply liberally before sun exposure
    • reapply after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every two hours
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  • Other Information

    Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease theis risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 am - 2 pm
    • wear long-sleeve shirts, patns, hats and sunglasses
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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, 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, Propylparaben.

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  • Questions or Comments?

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

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  • Principal Display Panel

    Tear Here

    TROPICAL
    flavor

    HAWAIIAN Tropic®
    LIP BALM
    Stick Sunscreen

    Broad SPectrum
    SPF 45+

    45+
    UVB & UVB
    protection

    water resistant
    (80 minutes)

    63354-300-61
    NET WT .14 OZ. (4 g)

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  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC 
    avobenzone, octocrylene, oxybenzone stick
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63354-300
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 1 g  in 100 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 10 g  in 100 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 6 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ETHYLHEXYL PALMITATE  
    MEDIUM-CHAIN TRIGLYCERIDES  
    DIISOBUTYL ADIPATE  
    CETYL ALCOHOL  
    CYCLOMETHICONE 5  
    CYCLOMETHICONE 6  
    DIMETHICONE  
    POLYETHYLENE GLYCOL 400  
    SACCHARIN SODIUM DIHYDRATE  
    PROPYLPARABEN  
    ALOE VERA LEAF  
    BUTYLATED HYDROXYTOLUENE  
    MINERAL OIL  
    PAPAYA  
    MANGO  
    PLUMERIA RUBRA FLOWER  
    COLOCASIA ESCULENTA ROOT  
    GUAVA  
    PASSIFLORA INCARNATA FRUIT  
    VITAMIN A PALMITATE  
    ASCORBIC ACID  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    OCTYLDODECANOL  
    SILICON DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63354-300-63 4 g in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/11/2012
    Labeler - Energizer Personal Care LLC (021718141)
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