Panama Jack
FDA Label NDC 58443-0056

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 58443-0056). 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, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 2 %, Homosalate 7.5 %, Octisalate  5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

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

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

  • spray liberally and evenly spread by hand 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 a 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
      • 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

Diethylhexyl 2,6-Naphhalate, Fragrance (Parfum), Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

  • protect this product from excesive heat and direct sun. May stain some fabrics

Principal Display Panel - 177 Ml  Bottle Label

Principal Display Panel (177 mL Bottle Label)

Principal Display Panel (177 mL Bottle Label)

Panama Jack

SPF 30

BROAD SPECTRUM SPF 30+

CONTINUOUS CLEAR

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

QUICK & EVEN COVERAGE

6 FL OZ (177 mL)

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