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| Product NDC Code | 82589-000 | ||||
|---|---|---|---|---|---|
| Drug Name | Ist sunscreen spf 50 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | IST DIVING SYSTEM, INC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide (Non-Nano) 8.5% Zinc Oxide (Non-Nano) 1.0% Purpose Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Sunscreen lotion in SPF50 for all skin types, Anti-Jellyfish formula to prevent stung. Reef friendly(Octinoxate & Oxybenzone Free)
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.IST Sunscreen SPF 50 TITANIUM DIOXIDE, ZINC OXIDE CHLORPHENESIN PHENYL TRIMETHICONE STEARIC ACID DIMETHICONE ETHYLHEXYLGLYCERIN SQUALANE LAUROYL LYSINE .ALPHA.-TOCOPHEROL ACETATE MALTODEXTRIN HOREHOUND LAMINARIA OCHROLEUCA HELIANTHUS ANNUUS SPROUT SODIUM BENZOATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION CAPRYLYL TRISILOXANE WATER MEDIUM-CHAIN TRIGLYCERIDES BUTYLENE GLYCOL ETHYLHEXYL STEARATE CYCLOMETHICONE 5 ALKYL (C12-15) BENZOATE GLYCERIN ISONONYL ISONONANOATE TALC MAGNESIUM SULFATE, UNSPECIFIED FORM SODIUM CHLORIDE ALUMINUM OXIDE PHENOXYETHANOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Labeling: Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Contact: [email protected]
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor ir rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API