Label: HAWAIIAN TROPIC - avobenzone, octocrylene and oxybenzone lotion

  • NDC Code(s): 63354-315-11, 63354-315-54
  • 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 3%
    Oxybenzone 3%
    Close
  • Purpose

    Sunscreen

    Close
  • Use


    helps prevent sunburn
    Close
  • 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.
    Close
  • 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
    Close
  • 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.
    Close
  • Inactive Ingredients

    Water, Diisopropyl Adipate, Ethylhexyl Benzoate, Glyceryl Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Glycerin, Hydrated Silica, Mica, Polyglyceryl-3 Methylglucose Distearate, PEG-100 Stearate, Dimethicone, Sodium Polyacrylate, Titanium Dioxide, Chlorphenesin, Silica, Paraffin, Disodium EDTA, PEG-8 Dimethicone, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Aloe Barbadensis Leaf Juice, Octyldodecanol, Retinyl Palmitate, Tocopheryl Acetate, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance.

    Close
  • Questions or Comments?

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

    Close
  • Principal Display Panel

    HAWAIIAN

    Tropic®

    Shimmer
    EFFECTTM

    Lotion Sunscreen
    with mica minerals

    BROAD SPECTRUM

    SPF 20

    20
    UVA & UVB protection
    water resistant (80 minutes)

    highlights your skin tone

    Protect ● Pamper ● Nourish

    6 FL. OZ. (177 mL)

    HT Shimmer 20 6 oz
    HT Shimmer 20 2 oz
    Close
  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC 
    avobenzone, octocrylene, oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63354-315
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 2 g  in 100 g
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 3 g  in 100 g
    OXYBENZONE (OXYBENZONE) OXYBENZONE 3 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    DIISOPROPYL ADIPATE  
    GLYCERYL MONOSTEARATE  
    GLYCERIN  
    HYDRATED SILICA  
    MICA  
    POLYOXYL 100 STEARATE  
    DIMETHICONE  
    TITANIUM DIOXIDE  
    CHLORPHENESIN  
    SILICON DIOXIDE  
    PARAFFIN  
    EDETATE DISODIUM  
    ALOE VERA LEAF  
    OCTYLDODECANOL  
    VITAMIN A PALMITATE  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    ASCORBIC ACID  
    PHENOXYETHANOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63354-315-54 182 g in 1 BOTTLE
    2 NDC:63354-315-11 61 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/30/2010
    Labeler - Energizer Personal Care LLC (021718141)
    Close