FDA.reportPublic FDA data

Panama Jack 100 Broad Spectrum SPF 100 Sunscreen Continuous Spray

Manufacturer
Prime Packaging Inc. | Prime Enterprises Inc
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:07

Label at a glance#

ProductPanama Jack Broad Spectrum SPF 100 Sunscreen
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 spread evenly by hand 15 minutes before sun exposure. 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. Reapply: after 80 minutes of swimming and sweating. immediately after towel drying. at least every 2 hours. Sun Protection Measures . Spending time in the sun...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Oxybenzone 6%

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

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. Risne with water to remove.

Keep away from face to avoid breathing it. Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120ºF.

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.

SPL UNCLASSIFIED SECTION

Flammable Do not use near heat, flame or while smoking.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray liberally and spread evenly by hand 15 minutes before sun exposure.
  • 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.
  • Reapply:
  • after 80 minutes of swimming and 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

Caprylic/Capric Triglyceride, Diethylhexyl Syringylidene-malonate, Fragrance, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.
  • Avoid spraying on fabrics-could cause discoloration.

Question or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-840-5225

Panama Jack 100 Broad Spectrum SPF 100 Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0124-42023-01-30C16284748780-1f386c649-c646-0266-e053-dadaa90a7c1aPanama Jack 100 Broad Spectrum SPF 100 Sunscreen Continuous Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0124-4Panama JackBroad Spectrum SPF 100 Sunscreen177 mL in 1 CANSPRAY1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0124PANAMA JACK BROAD SPECTRUM SPF 100 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING INC.]2Legacy NDC, 1 package rows20200118_67500b02-6c91-3d10-e053-2991aa0ac295.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-012413630-0124-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALCOHOL3K9958V90MIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
VINYL ACETATEL9MK238N77IACT
MONOBUTYL MALEATEF2LD7FVO1LIACT
ISOBORNYL ACRYLATEIX0PRH184PIACT

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
9c5be6dd-2781-299e-e053-2995a90ada8467500b02-6c91-3d10-e053-2991aa0ac2952020-01-17WarningsExact identifier
spl id: 9c5be6dd-2781-299e-e053-2995a90ada84
spl set id: 67500b02-6c91-3d10-e053-2991aa0ac295

Reported adverse events (FAERS/openFDA)#

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