Label: HAWAIIAN TROPIC ISLAND SPORT SPF 30- avobenzone and octocrylene and oxybenzone spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 27, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 0.01mL / 1mL

    Octocrylene 0.077mL / 1mL

    Oxybenzone 0.03mL / 1mL

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn

  • Warnings

    For external use only

    Do not spray directly into face

    Flammable: do not use near heat, flame, or while smoking

    When using this product

    avoid spraying in eyes. If contact occurs, rinse thoroughly with water.

    do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

    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.

  • Directions

    apply generously and evenly to all areas 15 minutes before sun exposure

    spray on hands to apply to face

    use in well-ventilated area

    reapply at frequent intervals and after swimming or towel drying

    ask a doctor before use on children under six months of age

  • 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.

  • Inactive Ingredients

    SD Alcohol 40-B, Acrylates/Octylacrylamide Copolymer, Caprylyl Glycol, 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 Flower Extract, Colocasia Antiquorum Root Extract, Psidium Guajava Fruit Extract, Passiflora Incarnata Fruit Extract, Mineral Oil, Aloe Barbadensis Leaf Extract, Fragrance.

  • Questions or Comments?

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

    Distributed by:
    TANNING RESEARCH
    LABORATORIES,LLC
    Ormond Beach, FL 32174
    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL

    NEW
    HAWAIIAN
    Tropic    ®
    ISLAND
    sportTM
    Clear Spray Sunscreen
    hydrates skin
    very water resistant
    skin-nourishing antioxidants
    30
    UVB/SPF
    WITH UVA
    SUNSURE
    ProtectionTM
    Protect Pamper Nourish
    6 FL. OZ. (177 ml)

    PRINCIPAL DISPLAY PANEL Hawaiian Tropic Island Sport SPF 30

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC ISLAND SPORT SPF 30 
    avobenzone and octocrylene and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.01 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.077 mL  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.03 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PAPAYA (UNII: KU94FIY6JB)  
    MANGO (UNII: I629I3NR86)  
    PLUMERIA EXTRACT (UNII: LGC8P2PC4H)  
    GUAVA (UNII: 74O70D6VG0)  
    PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2035-1177 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35210/03/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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