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

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PANAMA JACK SPF 4 DARK TANNING OIL (OCTINOXATE) OIL [PRIME ENTERPRISES INC.]
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NDC 58443-0201-4
Set ID 22b43c46-4cd4-0cbb-e054-00144ff88e88
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

    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 or comments?

  • Panama Jack SPF 4 Dark Tanning Oil

    Principal Display Image

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  SPF 4 DARK TANNING OIL
    octinoxate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0201-4198.7 g in 1 BOTTLE; Type 0: Not a Combination Product12/15/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/15/2011
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028manufacture(58443-0201) , pack(58443-0201) , label(58443-0201)
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