Label: PANAMA JACK SPF 8- avobenzone, octocrylene lotion

  • NDC Code(s): 58443-0282-4
  • Packager: Prime Enterprises Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 12, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredients

    Avobenzone 2%

    Octocrylene 2%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn

  • Warnings

    Skin Cancer/Skin Aging Alert: Specnding 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 hours

    • children under 6 months: Ask a doctor

  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Cetyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, Isopropylphthalimide, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate, Ubiquinone, Water, Xanthan Gum

  • Other information

    • protect this product from excessive heat and direct sun

    • avoid contact with fabrics - could cause discoloration

  • Questions or comments?

    Call toll free 1-800-840-5225

  • Panama Jack 8 SPF 8 Sunscreen Lotion

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    PANAMA JACK  SPF 8
    avobenzone, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0282
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.68 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.68 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0282-4177 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/15/2019
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0282) , manufacture(58443-0282) , label(58443-0282) , analysis(58443-0282)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!