PANAMA JACK SPF 4 (OCTINOXATE) OIL [PRIME ENTERPRISES, INC.]

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PANAMA JACK SPF 4 (OCTINOXATE) OIL [PRIME ENTERPRISES, INC.]
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NDC 58443-0066-3
Set ID 4783911d-afb2-488c-9666-561c5bd5150e
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 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
      • at least every 2 hours
    • children under 6 months: Ask a doctor

  • Inactive Ingredients

    Aloe Barbadensis Extract, Arachis Hypogaea (Peanut) Oil, Citrus Medica Limonum (Lemon) Peel Oil, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Olea Europaea (Olive) Fruit Oil, Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Theobroma Cacao (Cocoa) Seed Butter

  • Other information

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

    Questions or Comments?

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

  • PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 237mL Bottle Label


    Panama jack

    SPF 4

    Dark

    Tanning Oil

    Exotic Natural Oils

    Fruit & Nut Extracts

    Light Sunscreen Formula

    8 FL OZ (237 mL)

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  SPF 4
    octinoxate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE16.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEANUT OIL (UNII: 5TL50QU0W4)  
    LEMON OIL (UNII: I9GRO824LL)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0066-3237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/24/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/24/2013
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0066) , pack(58443-0066) , manufacture(58443-0066) , analysis(58443-0066)
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