Label: HAWAIIAN TROPIC TANNING DRY SPF 6- avobenzone and octocrylene and oxybenzone oil

  • 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 25, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 0.005mL / 1mL

    Octocrylene 0.035mL / 1mL

    Oxybenzone 0.015mL / 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

    Mineral Oil, Ethylhexyl Palmitate, Diisopropyl Adipate, Isopropyl Myristate, Silica, Cocos Nucifera (Coconut) Oil, Fragrance, Theobroma Cacao (Cocoa) Seed Butter, Amyl Acetate, Aloe Barbadensis Leaf Extract, Plumeria Acutifolia (Plumerica) Flower Extract, Mangifera Indica (Mango) Fruit Extract, Psidium Guajava (Guava) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Passiflora Incarnata (Passionflower) Fruit Extract, Colocasia Antiquorum Root Extract, Tocopheryl Acetate (Vitamin E), Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A).

  • 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 LOOK
    HAWAIIAN
    Tropic    ®
    TANNING
    Dry Oil
    Clear Spray Sunscreen
    exotic island botanicals
    skin-nourishing antioxidants
    ultra moisturi    zing
    6
    UVB/SPF
    WITH     UVA
    Protect     Pamper    Nourish
    6 FL. OZ. (177 ml)

    PRINCIPAL DISPLAY PANEL Hawaiian Tropic Tanning Dry Oil SPF 6

  • INGREDIENTS AND APPEARANCE
    HAWAIIAN TROPIC TANNING DRY SPF 6 
    avobenzone and octocrylene and oxybenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.005 mL  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.035 mL  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.015 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AMYL ACETATE (UNII: 92Q24NH7AS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PLUMERIA EXTRACT (UNII: LGC8P2PC4H)  
    GUAVA (UNII: 74O70D6VG0)  
    PAPAYA (UNII: KU94FIY6JB)  
    PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOCOLATE (UNII: D9108TZ9KG)  
    MANGO (UNII: I629I3NR86)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2013-1177 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35205/20/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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