FDA.reportPublic FDA data

Panama Jack

Manufacturer
Prime Enterprises Inc.
Effective date
2021-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:56:44

Label at a glance#

ProductPanama Jack SPF 4 Dark Tanning Oil
Active ingredientOCTOCRYLENE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

spray liberally and spread evenly by hand 15 minutes before sun exposure do not spray directly into face. Spray on hands then apply to face reapply: after swimming or sweating inmediately after towel drying at least every 2 hours children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 2%

Purpose

OTC - PURPOSE SECTION

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.

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. Keep away from face to avoid breathing it.

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

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • do not spray directly into face. Spray on hands then apply to face
  • reapply:
  • after swimming or sweating
  • inmediately after towel drying
  • at least every 2 hours
  • children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arachis Hypogaea (Peanut) Oil, Citrus Medica Limonum (Lemon) Peel Oil, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Theobroma Cacao (Cocoa) Seed Butter

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun
  • avoid spraying on fabrics-could cause discoloration

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-840-5225

Panama Jack 4 SPF 4 Sunscreen Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-028758443-0287-4

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
LEMON OILI9GRO824LLIACT
ALMOND OIL66YXD4DKO9IACT
MINERAL OILT5L8T28FGPIACT
COCOA BUTTER512OYT1CRRIACT
ALOE VERA LEAFZY81Z83H0XIACT
OLIVE OIL6UYK2W1W1EIACT
COCONUT OILQ9L0O73W7LIACT
OCTOCRYLENE5A68WGF6WMACTIB
PEANUT OIL5TL50QU0W4IACT

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
b8cae052-44a3-6256-e053-2995a90a418a938c4797-8aee-1845-e053-2995a90ade9f2021-01-13WarningsExact identifier
spl id: b8cae052-44a3-6256-e053-2995a90a418a
spl set id: 938c4797-8aee-1845-e053-2995a90ade9f

Reported adverse events (FAERS/openFDA)#

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