IST SUNSCREEN SPF 50- titanium dioxide, zinc oxide cream

IST Sunscreen SPF 50 by

Drug Labeling and Warnings

IST Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by IST DIVING SYSTEM, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

Questions?

Contact: diving@istsports.com

Package Labeling:

INGREDIENTS AND APPEARANCE

IST SUNSCREEN SPF 50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82589-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	85 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SQUALANE (UNII: GW89575KF9)
LAUROYL LYSINE (UNII: 113171Q70B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
HOREHOUND (UNII: K08036XEJV)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82589-000-01	1 in 1 CARTON	04/01/2022
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2022

Labeler - IST DIVING SYSTEM, INC (860944404)