FDA.reportPublic FDA data

Panama Jack

Manufacturer
Prime Enterprises Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:17

Label at a glance#

ProductPanama Jack Broad Spectrum SPF 15 Sport
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Indications and 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.

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. 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 s...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

Octisalate 5%

Octocrylene 1.85%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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 SECTION

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.

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.
  • 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 Ingredients

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

  • may stain some fabrics
  • protect this product from excesive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-840-5225

Panama Jack Broad Spectrum SPF 15 Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0159-32024-01-30C16284748780-11030e365-6222-111a-e063-dadaa90a10e2Panama Jack Broad Spectrum SPF 15 Sport

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0159-3Panama JackBroad Spectrum SPF 15 Sport89 mL in 1 BOTTLELOTION892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0159PANAMA JACK BROAD SPECTRUM SPF 15 SPORT (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES INC.]2Legacy NDC, 1 package rows20200121_29c8cb02-25c2-0a43-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-015958443-0159-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
CETYL ALCOHOL936JST6JCNIACT
EDETATE DISODIUM7FLD91C86KIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
LICORICE61ZBX54883IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
UBIQUINONE Q2I7T5V2W47RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
STEARYL ALCOHOL2KR89I4H1YIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9c5a684e-99c3-676b-e053-2a95a90ac9ba29c8cb02-25c2-0a43-e054-00144ff88e882020-01-17WarningsExact identifier
spl id: 9c5a684e-99c3-676b-e053-2a95a90ac9ba
spl set id: 29c8cb02-25c2-0a43-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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