Label: IST SUNSCREEN SPF 50- titanium dioxide, zinc oxide cream

  • NDC Code(s): 82589-000-01
  • Packager: IST DIVING SYSTEM, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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  • 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:

    Label

  • INGREDIENTS AND APPEARANCE
    IST SUNSCREEN SPF 50 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82589-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE85 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82589-000-011 in 1 CARTON04/01/2022
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/01/2022
    Labeler - IST DIVING SYSTEM, INC (860944404)
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