FDA.reportPublic FDA data

Panama Jack

Manufacturer
Prime Enterprises Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:03:01

Label at a glance#

ProductPanama Jack SPF 85 Sport Dry Touch Sunscreen
Active ingredientOXYBENZONE, AVOBENZONE, HOMOSALATE, 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 broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, es...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 12.5%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 4%

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 - ASK DOCTOR 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 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 INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Fragrance, 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

Other Information

OTHER SAFETY INFORMATION

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

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-840-5225

Panama Jack Sport SPF 85 Dry Touch Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0221-32024-01-30C16284748780-11030e365-10ca-111a-e063-dadaa90a10e2Panama Jack Sport SPF 85 Dry Touch Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0221-3Panama JackSPF 85 Sport Dry Touch Sunscreen89 mL in 1 BOTTLESPRAY893

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0221PANAMA JACK SPF 85 SPORT DRY TOUCH SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES INC.]3Legacy NDC, 1 package rows20200118_2913eb8a-3cb0-21d4-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-022158443-0221-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
LICORICE61ZBX54883IACT
EDETATE DISODIUM7FLD91C86KIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
STEARYL ALCOHOL2KR89I4H1YIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
UBIQUINONE Q2I7T5V2W47RIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
METHYLPARABENA2I8C7HI9TIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
CETYL ALCOHOL936JST6JCNIACT

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
9c5a4018-022f-e92b-e053-2995a90a40162913eb8a-3cb0-21d4-e054-00144ff88e882020-01-17WarningsExact identifier
spl id: 9c5a4018-022f-e92b-e053-2995a90a4016
spl set id: 2913eb8a-3cb0-21d4-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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