Panama Jack

Manufacturer: Prime Enterprises, Inc.
Effective date: 2020-01-17
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:45:59

Label at a glance#

ProductPanama Jack SPF 30

Active ingredientTITANIUM DIOXIDE

Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-800-840-5225

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

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.

OTHER SAFETY INFORMATION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Hydroxide, Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diazolidinyl Urea, Disodium EDTA, Hexyl Laurate, Hydrogenated Castor Oil, Isopropyl Myristate, Methylparaben, Octyldodecanol, Polyethylene, Polyglyceryl-4 Isostearate, Propylparaben, Sodium Chloride, Stearic Acid, Tocopheryl Acetate, Water

Other information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or Comments?

Call toll free 1-800-840-5225

PRINCIPAL DISPLAY PANEL - 3.785 L Jug Label PRINCIPAL DISPLAY PANEL - 15 mL Foil Packet Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 3.785 L Jug Label

Panama Jack

SPF 30

Eco-Safe

SUNSCREEN LOTION

WATER RESISTANT (80 MINUTES)

Earth & Wildlife Friendly

1 Gallon-128 FL.OZ. (3.785L)

Panama Jack

SPF 30

Eco-Safe

SUNSCREEN LOTION

WATER RESISTANT (80 MINUTES)

Earth & Wildlife Friendly

0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Foil Packet Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER	INACTIVE INGREDIENT	7K68DGG29P	1
CETYL DIMETHICONE 45	INACTIVE INGREDIENT	IK315POC44	1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)	INACTIVE INGREDIENT	V2W71V8T0X	1
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	1
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

Panama Jack SPF 30
Titanium Dioxide
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER
ALLANTOIN
ALOE VERA LEAF
YELLOW WAX
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
CETYL DIMETHICONE 45
DIAZOLIDINYL UREA
EDETATE DISODIUM
HYDROGENATED CASTOR OIL
ISOPROPYL MYRISTATE
METHYLPARABEN
OCTYLDODECANOL
HIGH DENSITY POLYETHYLENE
POLYGLYCERYL-4 ISOSTEARATE
HEXYL LAURATE
PROPYLPARABEN
SODIUM CHLORIDE
.ALPHA.-TOCOPHEROL ACETATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58443-0069	58443-0069-9, 58443-0069-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER	7K68DGG29P	IACT
ALLANTOIN	344S277G0Z	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
YELLOW WAX	2ZA36H0S2V	IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)	V2W71V8T0X	IACT
CETYL DIMETHICONE 45	IK315POC44	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
HYDROGENATED CASTOR OIL	ZF94AP8MEY	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
OCTYLDODECANOL	461N1O614Y	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
POLYGLYCERYL-4 ISOSTEARATE	820DPX33S7	IACT
HEXYL LAURATE	4CG9F9W01Q	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
WATER	059QF0KO0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 431 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	FILM / TRANSDERMAL	32.44 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	LIQUID / TOPICAL	0.24 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, COATED / ORAL	25 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	GEL / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE, EXTENDED RELEASE / ORAL	4.53 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATUMOR	1.2 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TRANSDERMAL		113 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUPPOSITORY / RECTAL		140 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET, EXTENDED RELEASE / ORAL		393 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / EPIDURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
DIAZOLIDINYL UREA	DIAZOLIDINYL UREA	H5RIZ3MPW4	CREAM / TOPICAL		29 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SYSTEM / TRANSDERMAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
db11df64-4aed-2e54-e053-2a95a90ac7ce			ab340d4e-a4d4-4b53-98d8-531a0a5eb40a	2022-03-25	Warnings	Exact identifier spl set id: ab340d4e-a4d4-4b53-98d8-531a0a5eb40a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.