Panama Jack SPF 8 Bronzer Lotion C/S

Manufacturer
Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date
2020-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:33

Label at a glance#

ProductPanama Jack SPF 8
Active ingredientAVOBENZONE, OCTOCRYLENE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

spray liberally and spread evenly by hand 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 area

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2 %, Octocrylene 2 %

OTC - PURPOSE SECTION

Purpose

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.

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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F

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

Skin Cancer/Skin Aging Alert: Spending time in the sun increases you risk of skin cancer and early skin aging. this product has been shown only to prevent sunburn, not skin cancer or early aging.

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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 area

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Isopropylphthalimide, Oleth-10, Phenoxyethanol, Propylene Glycol, Retinyl Palmitate, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trimethylsiloxysilicate, Ubiquinone, Water

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0174-42023-01-30C16284748780-1f386c649-f469-0266-e053-dadaa90a7c1aPanama Jack SPF 8 Bronzer Lotion C/S

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0174-4Panama JackSPF 8155 g in 1 CANSPRAY1551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0174PANAMA JACK SPF 8 (AVOBENZONE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1Legacy NDC, 1 package rows20201014_b0a1da0f-9942-838b-e053-2995a90a7c61.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
13630-017413630-0174-4

Ingredients#

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

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

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
b0a1f884-0459-e8a9-e053-2a95a90a2170b0a1da0f-9942-838b-e053-2995a90a7c612020-10-01WarningsExact identifier
spl id: b0a1f884-0459-e8a9-e053-2a95a90a2170
spl set id: b0a1da0f-9942-838b-e053-2995a90a7c61

Reported adverse events (FAERS/openFDA)#

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