PANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]

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  • PANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]

PANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.]
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NDC 58443-0060-2, 58443-0060-3
Set ID 34bf67f5-0970-4edb-be95-278b9ace84bb
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Avobenzone  2 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 % 

  • PURPOSE

    Purpose

    Sunscreen

  • Uses

    • helps 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 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
    • 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 broad spectrum SPF of 15 of 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 Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Fragrance, Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Phenyl Trimethicone, Polyethylene, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Ubiquinone, Undecylcrylene Dimethicone, Water

  • Other information

    may stain some fabrics

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

    Questions or Comments?

    Call toll free 1-800-840-5225

  • PRINCIPAL DISPLAY PANEL - 177 mL  Bottle Label PRINCIPAL DISPLAY PANEL - 15mL Bottle Label 

    PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label

    The Original

    Panama Jack

    SURF 'N SPORT

    BROAD SPECTRUM

    SPF 30+

    Sunscreen Lotion

    WATER RESISTANT (80 MINUTES)

    Sheer Dry Touch

    Enriched with CoQ10 Antioxidant

    0.5 FL.OZ. (15mL.)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

    Panama jack

    SURF 'N SPORT

    BROAD SPECTRUM SPF 30+

    Sunscreen Lotion

    WATER RESISTANT (80 MINUTES)

    Sheer Dry Touch

    Enriched with CoQ10 Antioxidant

    3 FL OZ (90 mL)

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  BROAD SPECTRUM SPF 30
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.8 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE74.3 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.6 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27.3 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE19.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STYRENE (UNII: 44LJ2U959V)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0060-390 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2013
    2NDC:58443-0060-215 mL in 1 PACKET; Type 0: Not a Combination Product02/04/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/04/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0060) , pack(58443-0060) , manufacture(58443-0060) , analysis(58443-0060)
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