Active Ingredients
Avobenzone 2 %, Octocrylene 2 %
Panama Jack
FDA Label NDC 13630-0174
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 Packaging, Inc. for the product Panama Jack (NDC 13630-0174). 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, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, other safety information, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- helps prevent sunburn
Warnings
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.
Otc - When Using
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
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.
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
- 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
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
- protect this product from excesive heat and direct sun
- May stain some fabrics
Otc - Questions
Questions or Comments?
Call toll free 1 800 840-5225
Package Label.Principal Display Panel
Principal Display Label (13630 0174 4)
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