Ist Sunscreen Spf 50
FDA Label NDC 82589-000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ist Diving System, Inc for the product Ist Sunscreen Spf 50 (NDC 82589-000). 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, directions, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Titanium Dioxide (Non-Nano) 8.5%

Zinc Oxide (Non-Nano) 1.0%

Purpose

Sunscreen

Uses

Sunscreen lotion in SPF50 for all skin types, Anti-Jellyfish formula to prevent stung. Reef friendly(Octinoxate & Oxybenzone Free)

Directions

  • Apply liberally before sun exposure
  • Reapply: after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Children under 3 years of age: ask a doctor

Warnings

For external use only.

Do Not Use

on damaged or broken skin 

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

ir rash occurs. 

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Information

This product should not be used as guaranteed protection in jellyfish-infested waters, sting(s) can occur. In case of a sting(s), seek medical attention.

Caution

Please keep in a dry and clean place, avoid direct sunlights. If discomfort to product occurs, please discontinue and consult a dermatologist.

Inactive Ingredients

Water, Titanium Dioxide, Caprylyl Methicone, Caprylic/Capric Triglyceride, Butylene Glycol, Ethylhexyl Stearate, Lauryl PEG-10 Tris(Trimethylsiloxy) Silylethyl Dimethicone, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Glycerin, Isononyl isononanoate, Zinc Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Talc, Magnesium sulfate, Sodium chloride, Alumina, Phenoxyethanol, Chlorphenesin, Phenyl Trimethicone, Dimethiconol, Stearic Acid, Dimethicone, Ethylhexylglycerin, Dimethicone Crosspolymer, Squalane, Lauroyl Lysine, Tocopheryl Acetate, Maltodextrin, Marrubium Vulgare Extract, Laminaria Ochroleuca Extract, Caesalpinia Spinosa Fruit Extract, Helianthus Annuus Sprout Extract, Sodium Benzoate

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