Label: NEW HAWAIIAN TROPIC SENSITIVE SKIN LOTION SUNSCREEN- avobenzone and octocrylene and oxybenzone spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 19, 2010

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  • SPL UNCLASSIFIED SECTION

    New Hawaiian Tropic Sensitive Skin Lotion Spray Sunscreen

    Drug Facts

  • Active ingredients

    Avobenzone 3%

    Octocrylene 8%

    Oxybenzone 6%            

  • 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
  • While 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 way.

  • Directions

    • Shake well before use
    • 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

    Water, Dimethyl Ether, Butyloctyl Salicylate, Ethylhexyl Benzoate, Hydrogenated Dimer Dilinoleyl/Dimethylcarbonate Copolymer, Glycerin, Polymethylsilsesquioxane, Caprylyl Glycol, Ceteareth-25, Disodium Ethylene Dicocamide PEG-15 Disulfate, Dimethyl Capramide, Aloe Barbadensis Leaf Juice, Trocopherol, Retinyl Palmitate (vitamin A), Tocopheryl Acetate (vitamin E), Gossypium Herbaceum (cotton) seed extract, Stevia Rebaudiana leaf/stem extract, Tamanndus Indica Seed extract, Butylene Glycol, Pentylene glycol, BHT, Xanthan Gum, triethanolamine, Disodium EDTA, Phenoxyethanol, Hexylene Glycol, 

  • Questions or comments?

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

    Distributed by:
    Tanning Research Laboratories, LLC
    Ormond Beach, FL 32174
    www.hawaiiantropic.com

  • Principal Display Panel

    New Hawaiian Tropic
    Sensitive Skin
    Lotion Spray Sunscreen
    Oil free
    Hypoallergenic
    Skin-nourishing antioxidants
    50 UVB/SPF with UVA
    SunSure Protection TM 
    Protect Pamper Nourish
    Net Wt. 6 oz (170g)

    Principal Display Panel Hawaiian Tropic Sensitive Skin Lotion Spray Sunscreen 50 UVB/SPF with UVA Net Wt 6 oz (170g)

  • INGREDIENTS AND APPEARANCE
    NEW HAWAIIAN TROPIC SENSITIVE SKIN LOTION SUNSCREEN 
    avobenzone and octocrylene and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17630-2000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.08 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.06 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    LEVANT COTTON OIL (UNII: N5CFT140R8)  
    STEVIA LEAF (UNII: 6TC6NN0876)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17630-2000-1170 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/04/2009
    Labeler - Accra-Pac, Inc. (024213616)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accra-Pac, Inc.024213616MANUFACTURE
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