PANAMA JACK SPF 8 (OXTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.]

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  • PANAMA JACK SPF 8 (OXTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.]

PANAMA JACK SPF 8 (OXTINOXATE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.]
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Set ID 5779e99b-01f0-482c-8960-8de6a814e2f2
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 %, 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 hour
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Caramel, Carrageenan, Citric Acid, Dimethicone, Disodium EDTA, Fragrance, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Oleth 10, Propylene Glycol, Propylparaben, Soluble Collagen, Sorbitan Oleate, Tocopheryl Acetate, Triethanolamine, Trimethylsiloxysilicate, Water

  • Other information

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

    Questions or Comments?

    Call toll free 1-800-840-225          www.panamajack.com

  • PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label

    PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    Panama Jack

    SPF 8

    Spray Gel

    SUNSCREEN

    with

    INSTANT BRONZER

    WATER RESISTANT (80 MINUTES)

    Contains Aloe Vera and Vitamin E

    Non Greasy and Hypoallergenic

    8 FL OZ (237 mL)

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  SPF 8
    oxtinoxate, and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE19.8 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE19.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    3-BUTYLPHTHALIDE (UNII: 822Q956KGM)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARAMEL (UNII: T9D99G2B1R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OLETH-10 (UNII: JD797EF70J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0045-4237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/10/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/10/2012
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028label(58443-0045) , pack(58443-0045) , manufacture(58443-0045) , analysis(58443-0045)
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