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 23:03:10

Label at a glance#

ProductPanama Jack BROAD SPECTRUM SPF30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
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

spray liberally and evenly spread by hand 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 includin...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2 %, Homosalate 7.5 %, Octisalate  5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

OTC - PURPOSE SECTION

Purpose

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

WARNINGS SECTION

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

Flammable: Do no use near heat, flame or while smoking. Do not puncture or incinerate. Contents uner pressure. Do not store at temperatures above 120 0F.

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray liberally and evenly spread by hand 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
  • hold container 4 to 6 inches from the skin to apply.
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions. Use in well ventilated areas

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Diethylhexyl 2,6-Naphhalate, Fragrance (Parfum), Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

SPL UNCLASSIFIED SECTION

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

OTC - QUESTIONS SECTION

Questions or Comments?

Call toll free 1-800-840-5225

PRINCIPAL DISPLAY PANEL - 177 mL  Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 177 mL Bottle LabelPRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Panama Jack

SPF 30

BROAD SPECTRUM SPF 30+

CONTINUOUS CLEAR

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

QUICK & EVEN COVERAGE

6 FL OZ (177 mL)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0056-42024-01-30C16284748780-11030e365-6f24-111a-e063-dadaa90a10e29038027c-b36b-484d-997b-7412f9afef46

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0056-4Panama JackBROAD SPECTRUM SPF30177 mL in 1 BOTTLESPRAY1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0056PANAMA JACK BROAD SPECTRUM SPF30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME ENTERPRISES, INC.]3Legacy NDC, 1 package rows20200118_9038027c-b36b-484d-997b-7412f9afef46.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-005658443-0056-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
ALCOHOL3K9958V90MIACT
DIBUTYL MALEATE4X371TMK9KIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

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
9c581024-2d6d-1deb-e053-2995a90adf849038027c-b36b-484d-997b-7412f9afef462020-01-17WarningsExact identifier
spl id: 9c581024-2d6d-1deb-e053-2995a90adf84
spl set id: 9038027c-b36b-484d-997b-7412f9afef46

Reported adverse events (FAERS/openFDA)#

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