PANAMA JACK 30 BROAD SPECTRUM SPF 30 CLEAR ZINC- octinoxate, octisalate, octocrylene, and zinc oxide 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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Active ingredients Octinoxate 5%, Octisalate 5%, Octocrylene 2%, Zinc Oxide 3%

Purpose

Sunscreen

Uses • Helps prevent sunburn •If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings • For external use only • Do not use on damaged or broken skin • When using this productkeep out of eyes. Rinse with water to remove. • Stop use and ask a doctorif 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 • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: •limit time in the sun, especially from 10 a.m. - 2 p.m. •wear long-sleeve shirts, pants, hats, and sunglasses •children under 6 months: Ask a doctor.

Inactive Ingrediets

Aluminium Starch Octenylsuccinate, Bis-PEG-12 Dimethicone Beeswax, Cetyl PEG/PPG-10/1 Dimethicone, Decyl Glucoside, Diazolidinyl Urea, Diisodecyl Adipate, Disodium EDTA, Glycerin, Hexyl Laurate, Hydrogenated Castor Oil, Methylparaben, Mineral Oil, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Silica, Sodium Chloride, Tocopheryl Acetate, Triethoxycaprylysilane, Water

Other information Protect this product from excessive heat and direct sun

Distributed by: Panama Jack, Inc. Orlando, FL. 32801 1-800-840-5225

PRINCIPAL DISPLAY PANEL - 30mL  Bottle Label

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

Panama Jack

SUNSCREEN

LOTION

1 FL OZ (30mL)

30 BROAD SPECTRUM SPF 30

CLEAR ZINC

WATER RESISTANT (80 MINUTES)

PANAMA JACK  30 BROAD SPECTRUM SPF 30 CLEAR ZINC
octinoxate, octisalate, octocrylene, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0179
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE49.35 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE49.35   in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE19.74   in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION29.61 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
BIS-PEG-10 DIMETHICONE/DIMER DILINOLEATE COPOLYMER (UNII: CF5W1YCX11)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
DIISODECYL ADIPATE (UNII: 3V0Q382O0P)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MINERAL OIL (UNII: T5L8T28FGP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0179-330 mL in 1 BOTTLE; 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 Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028label(58443-0179) , pack(58443-0179) , manufacture(58443-0179) , analysis(58443-0179)

Revised: 1/2020
Document Id: 9c5a0b7d-ec31-ef9b-e053-2995a90a1824
Set id: 82c56c45-1f18-418d-946b-d320b9369258
Version: 3
Effective Time: 20200117
 
Prime Enterprises, Inc.