Label: PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC- octinoxate, octisalate, octocrylene, and zinc oxide lotion

  • NDC Code(s): 58443-0179-3
  • Packager: Prime Enterprises, Inc.
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 21, 2018

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  • Active ingredients Octinoxate 5%, Octisalate 5%, Octocrylene 2%, Zinc Oxide 3%

  • Purpose

    Sunscreen

  • UsesHelps prevent sunburn •If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings For external use only Do not use on damaged or broken skin • When using this productkeep out of eyes. Rinse with water to remove. • Stop use and ask a doctorif rash occurs. • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions •apply liberally 15 minutes before sun exposure •reapply: after 80 minutes of swimming or sweating •immediately after towel drying •at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m. - 2 p.m. •wear long-sleeve shirts, pants, hats, and sunglasses •children under 6 months: Ask a doctor.

  • Inactive Ingrediets

    Aluminium Starch Octenylsuccinate, Bis-PEG-12 Dimethicone Beeswax, Cetyl PEG/PPG-10/1 Dimethicone, Decyl Glucoside, Diazolidinyl Urea, Diisodecyl Adipate, Disodium EDTA, Glycerin, Hexyl Laurate, Hydrogenated Castor Oil, Methylparaben, Mineral Oil, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Silica, Sodium Chloride, Tocopheryl Acetate, Triethoxycaprylysilane, Water

  • OTHER SAFETY INFORMATION

    Other information Protect this product from excessive heat and direct sun

    Distributed by: Panama Jack, Inc. Orlando, FL. 32801 1-800-840-5225

  • PRINCIPAL DISPLAY PANEL - 30mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

    Panama Jack

    SUNSCREEN

    LOTION

    1 FL OZ (30mL)

    30 BROAD SPECTRUM SPF 30

    CLEAR ZINC

    WATER RESISTANT (80 MINUTES)

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  30 BROAD SPECTRUM SPF 30 CLEAR ZINC
    octinoxate, octisalate, octocrylene, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0179
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE49.35 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.35   in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.74   in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION29.61 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DIISODECYL ADIPATE (UNII: 3V0Q382O0P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0179-330 mL in 1 BOTTLE; Type 0: Not a Combination Product12/29/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/29/2011
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0179) , pack(58443-0179) , manufacture(58443-0179) , analysis(58443-0179)