FDA.reportPublic FDA data

IST Sunscreen SPF 50

Manufacturer
IST DIVING SYSTEM, INC
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:05:45

Label at a glance#

ProductIST Sunscreen SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (Non-Nano) 8.5%

Zinc Oxide (Non-Nano) 1.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin 

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor 

OTC - STOP USE SECTION

ir rash occurs. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Information

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Contact: diving@istsports.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82589-000-012025-01-30C16284748780-12cef2736-9cca-d83d-e063-dadaa90ab31fIST Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82589-000-01IST Sunscreen SPF 501 in 1 CARTONCREAM13
82589-000-01IST Sunscreen SPF 50100 mL in 1 TUBECREAM1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82589-000IST SUNSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [IST DIVING SYSTEM, INC]3Legacy NDC, 2 package rows20231227_e69b1338-7dae-4765-a60e-91d06eadf595.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82589-00082589-000-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORPHENESINI670DAL4SZIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
STEARIC ACID4ELV7Z65APIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SQUALANEGW89575KF9IACT
LAUROYL LYSINE113171Q70BIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MALTODEXTRIN7CVR7L4A2DIACT
HOREHOUNDK08036XEJVIACT
LAMINARIA OCHROLEUCA4R2124HE76IACT
HELIANTHUS ANNUUS SPROUT4P26HG1S5WIACT
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
CYCLOMETHICONE 50THT5PCI0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
TALC7SEV7J4R1UIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALUMINUM OXIDELMI26O6933IACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d6bb92a-8442-9847-e063-6394a90ac78fe69b1338-7dae-4765-a60e-91d06eadf5952023-12-26WarningsExact identifier
spl id: 0d6bb92a-8442-9847-e063-6394a90ac78f
spl set id: e69b1338-7dae-4765-a60e-91d06eadf595

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.