Panama Jack
FDA Label NDC 58443-0066

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 58443-0066). 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 principal display panel - 237 ml  bottle label, active ingredients, uses, 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, otc - stop use, 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

Principal Display Panel - 237 Ml  Bottle Label

Principal Display Panel (237mL Bottle Label)

Principal Display Panel (237mL Bottle Label)


Panama jack

SPF 4

Dark

Tanning Oil

Exotic Natural Oils

Fruit & Nut Extracts

Light Sunscreen Formula

8 FL OZ (237 mL)

Active Ingredients

Octinoxate 2 %

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 - 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

* Please review the disclaimer below.