PANAMA JACK BROAD SPECTRUM SPF 15 SPORT- avobenzone, octisalate, and octocrylene lotion 
Prime Enterprises Inc.

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.

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Panama Jack Broad Spectrum SPF 15 Sport

Active Ingredients

Avobenzone 2%

Octisalate 5%

Octocrylene 1.85%

Purpose

Sunscreen

Uses

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

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, C12-15 Alkyl Benzoate, Cetyl Alcohol, Disodium EDTA, Fragrance (Parfum), Glycyrrhiza Glabra (Licorice) Root Extract, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Phenyl Trimethicone, Polyethylene, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Propylparaben, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Ubiquinone, Undecylcrylene Dimethicone, Water (Aqua)

Other Information

Questions or comments?

Call toll free 1-800-840-5225

Panama Jack Broad Spectrum SPF 15 Sunscreen

Principal Display Image

PANAMA JACK  BROAD SPECTRUM SPF 15 SPORT
avobenzone, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0159
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE19.6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE18.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
LICORICE (UNII: 61ZBX54883)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)  
UBIQUINONE Q2 (UNII: I7T5V2W47R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0159-389 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2000
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/11/2000
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0159) , manufacture(58443-0159) , label(58443-0159) , analysis(58443-0159)

Revised: 1/2020
Document Id: 9c5a684e-99c3-676b-e053-2a95a90ac9ba
Set id: 29c8cb02-25c2-0a43-e054-00144ff88e88
Version: 2
Effective Time: 20200117
 
Prime Enterprises Inc.