Active Ingredients
Avobenzone 3% Octocrylene 2.75%
Homosalate 15% Oxybenzone 4%
Octisalate 5%
Panama Jack
FDA Label NDC 58443-0257
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises Inc. for the product Panama Jack (NDC 58443-0257). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
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.
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes.
Rinse with water to remove.
Otc - Ask Doctor
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
• apply liberally 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 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
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Fragrance, Isopropylphthalimide, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Ubiquinone, Undecylcrylene Dimethicone, Water
Other Information
• may stain some fabrics.
• protect this product from excessive heat and direct sun
Questions Or Comments?
Call toll free 1-800-840-5225
100 Broad Spectrum Spf 100 Panama Jack Sport Sunscreen Lotion
Principal Display Label (58443 0257 3)
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