Label: HAWAIIAN TROPIC - avobenzone, octocrylene and oxybenzone lotion

  • NDC Code(s): 63354-303-11, 63354-303-53, 63354-303-56, 63354-303-57
  • 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 12/12

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

  • Active Ingredients


    Avobenzone 2%
    Octocrylene 5%
    Oxybenzone 3%
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  • Purpose

    Sunscreen

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  • Use


    helps prevent sunburn
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  • Warnings

    For external use only.

    When using this product

    do not get into eyes. If contact occurs, rinse throughly with water.

    Stop use and ask a doctor if

    irritation or rash develops

    Keep out of reach of children

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

    • apply generously and evenly to all areas 15 minutes before sun exposure
    • reapply at frequent intervals and after swimming or towel drying
    • ask a doctor before use on children under six months of age
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  • Other Information


    Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.
    • May stain some fabrics.
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  • Inactive Ingredients

    Water, Ethylhexyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-10 Phosphate, Retinyl Palmitate (Vitamin A), Ascorbic Acid (Vitamin C), Tocopheryl Acetate (Vitamin E), PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Octyldodecanol, Silica, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Plumeria Acutifolia (Plumeria) Flower Extract, Colocasia Antiquorum Root Extract, Psidium Guajava (Guava) Fruit Extract, Passiflora Incarnata (Passionflower) Fruit Extract, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea Butter), Mangifera Indica (Mango) Seed Butter, Phenethyl Benzoate, Polymethylsilsesquioxane, Neopentyl Glycol Diheptanoate, VP/Eicosene Copolymer, Coco-Glucoside, Caprylyl Glycol, Glycerin, Dimethicone, Paraffin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Xanthan Gum, Triethanolamine, Phenoxyethanol, Propylparaben, Methylparaben, Fragrance.

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  • Questions or Comments?

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

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  • Principal Display Panel

    HAWAIIAN
    Tropic
    ®

    SHEER TOUCH
    Lotion Sunscreen

    BROAD SPECTRUM

    SPF 30

    30

    UVA/UVB protection
    water resistant (80 minutes)

    skin-nourishing antioxidants

    Protect ● Pamper ● Nourish

    8 FL. OZ. (237 mL)

    HT Sheer Touch SPF 30 8 oz

    HT Sheer Touch SPF 30 10.8 oz

    HT Sheer Touch SPF 30 4 oz

    HT Sheer Touch SPF 30 2 oz

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  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC 
    avobenzone, octocrylene, oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-303
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63354-303-56 237 g in 1 BOTTLE
    2 NDC:63354-303-57 319 g in 1 BOTTLE
    3 NDC:63354-303-53 118 g in 1 BOTTLE
    4 NDC:63354-303-11 59 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/28/2010
    Labeler - Energizer Personal Care LLC (021718141)
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