Label: PANAMA JACK SPF 15- octinoxate, octisalate 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 January 17, 2020

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  • Active ingredients

    Octinoxate 5 %, Octisalate 3 % and Oxybenzone 2 %

  • PURPOSE

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if 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
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Dimethicone, Disodium EDTA, Fragrance (Parfum), Glyceryl Stearate, Isopropylphthalimide, Methylisothiazolinone, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propylene Glycol, Stearyl Alcohol, Tocopheryl Acetate, Triethanolamine, Ubiquinone, Water (Aqua), Xanthan Gum

  • Other information

    • protect this product from excesive heat and direct sun
  • QUESTIONS

    Questions or Comments?

    Call toll free 1-800-840-5225 www.panamajack.com

    Email us at info@panamajack.com

  • PRINCIPAL DISPLAY PANEL - 177 mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

    Panama Jack

    SPF 15

    SUNSCREEN

    Lotion

    WATER RESISTANT (80 MINUTES)

    Non Greasy & Hypoallergenic with

    CoQ10 Antioxidant, Green Tea & Vitamin E

    6 FL OZ (177 mL)

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  SPF 15
    octinoxate, octisalate and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE48.4 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE29 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE19.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0052-4177 mL in 1 BOTTLE; Type 0: Not a Combination Product02/25/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/25/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0052) , pack(58443-0052) , manufacture(58443-0052) , analysis(58443-0052)
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