FDA.reportPublic FDA data

Panama Jack Sport Broad Spectrum SPF 8 Sunscreen Spray

Manufacturer
Prime Packaging, Inc. | Prime Enterprises, Inc.
Effective date
2021-11-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:26:48

Label at a glance#

ProductPanama Jack Broad Spectrum SPF 8
Active ingredientAVOBENZONE, OCTOCRYLENE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

Spray l iberally and spray evenly by hand 15 minutes before sun exposure Reapp l y: after 80 minutes of swimming or sweating. immediate l y after towel drying. at l east 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 areas

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%

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 sunincreases your risk of skin cancer and early sking aging. This product has been shown on ly to prevent sunburn, not skin cancer or early sking 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. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

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 spray evenly by hand 15 minutes before sun exposure
  • Reapp ly:
  • after 80 minutes of swimming or sweating.
  • immediate ly 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 areas

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 excessive heat and direct sun.
  • May stain some fabrics

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-840-5225

Panama Jack Sport Broad Spesctrum SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display LabelPrinciple Display Label

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13630-018913630-0189-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITAN MONOOLEATE06XEA2VD56IACT
COCOA BUTTER512OYT1CRRIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
SODIUM HYDROXIDE55X04QC32IIACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
OLETH-10JD797EF70JIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
UBIDECARENONEEJ27X76M46IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CARAMELT9D99G2B1RIACT
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)78GX033D7IIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT

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
d0898bca-0793-7825-e053-2a95a90a7098d0898bbe-3ad4-56f5-e053-2a95a90a0d6a2021-11-11WarningsExact identifier
spl id: d0898bca-0793-7825-e053-2a95a90a7098
spl set id: d0898bbe-3ad4-56f5-e053-2a95a90a0d6a

Reported adverse events (FAERS/openFDA)#

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