PANAMA JACK SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.]

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  • PANAMA JACK SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.]

PANAMA JACK SPF 15 (OCTINOXATE, OCTISALATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.]
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NDC 58443-0055-4
Set ID 549dd925-5336-4f4b-ab7c-e6581d27428e
Category HUMAN OTC DRUG LABEL
Packager Prime Enterprises, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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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. Keep away from face to avoid breathing it.

    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.

    Flammable: Do no use near heat, flame or while smoking. Do not puncture or incinerate. Contents uner pressure. Do not store at temperatures above 120 0F.

  • Directions

    • Spray liberally and spread evenly by hand 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
    • Hold container 4 to 6 inches from the skin to apply.
    • Do not spray directly ino face. Spray on hands then apply to face.
    • Do not apply in windy conditions. Use in well ventilated areas.
  • Inactive Ingredients

    C12-15 Alkyl Benzoate, Fragrance (Parfum), SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

  • Other information

    • protect this product from excesive heat and direct sun. may stain some fabrics
  • QUESTIONS

    Questions or Comments?

    Call toll free 1-800-840-5225

  • PRINCIPAL DISPLAY PANEL - 177 mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

    Panama Jack

    SPF 15

    CONTINUOUS CLEAR

    SUNSCREEN SPRAY

    WATER RESISTANT (80 MINUTES)

    NON-GREASY FORMULA

    QUICK & EVEN COVERAGE

    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:58443-0055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40.8 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE24.5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE16.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0055-4177 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/15/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0055) , pack(58443-0055) , manufacture(58443-0055) , analysis(58443-0055)
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