PANAMA JACK SPF 8 WITH INSTANT BRONZER (OCINOXATE AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]

  • Home
  • PANAMA JACK SPF 8 WITH INSTANT BRONZER (OCINOXATE AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]

PANAMA JACK SPF 8 WITH INSTANT BRONZER (OCINOXATE AND OXYBENZONE) AEROSOL, SPRAY [PRIME PACKAGING, INC.]
PDF | XML
NDC 13630-0085-4
Set ID 131e6240-c282-4b04-b8d7-e45e8375f10e
Category HUMAN OTC DRUG LABEL
Packager Prime Packaging, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
View All Sections
  • Active ingredients

    Octinoxate 2 % and Oxybenzone 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 sunbrun, 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. Content under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

    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

    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • Children under 6 months: Ask a doctor
    • Hold container 4 to 6 inches from the skin to apply
    • Do not spray directly into face. Spray hands then apply to face.
    • Do not apply in windy conditions. Use in well ventilated areas.
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Diazolidinyl Urea, Dimethicone, Disodium EDTA, Fragrance, Isopropylphthalimide, Methylparaben, Oleth 10, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Trimethysiloxysilicate, water

  • Other information

    • protect this product from excesive heat and direct sun.
    • avoid spraying on fabrics-could cause discoloration.
  • Questions or Comments?

    Call toll free 1-800-840-5225

  • PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    Panama Jack

    8

    SUNSCREEN

    CONTINUOUS SPRAY

    INSTANT BRONZER

    QUICK & EVEN

    COVERAGE

    LIGHT FORMULA

    SPF 8

    WATER RESISTANT

    (80 MINUTES)

    6 FL OZ (177 mL)

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  SPF 8 WITH INSTANT BRONZER
    ocinoxate and oxybenzone aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0085
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE19.6 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE19.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARAMEL (UNII: T9D99G2B1R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OLETH-10 (UNII: JD797EF70J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0085-4177 mL in 1 CAN; Type 0: Not a Combination Product12/29/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/29/2011
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0085) , analysis(13630-0085)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0085) , pack(13630-0085)
View All Sections

Related Drugs

Search DailyMed Drugs