Panama Jack Spf 4 Dark Tanning Oil
Principal Display Image (58443 0201 4)
Panama Jack
FDA Label NDC 58443-0201
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 58443-0201). 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 panama jack spf 4 dark tanning oil, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octinoxate 2%
Purpose
Sunscreen
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.
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 - 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.
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- at least every 2 hours
- children under 6 months: Ask a doctor
Inactive Ingredients
Aloe Barbadensis Extract, Arachis Hypogaea (Peanut) Oil, Citrus Medica Limonum (Lemon) Peel Oil, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Olea Europaea (Olive) Fruit Oil, Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Theobroma Cacao (Cocoa) Seed Butter
Other Information
- protect this product from excessive heat and direct sun
Questions Or Comments?
- Call toll free 1-800-840-5225 www.panamajack.com
* Please review the disclaimer below.
