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| Product NDC Code | 69494-302 | ||||||||||||
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| Drug Name | Eryfotona actinica ultralight emulsion |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | EMULSION | ||||||||||||
| Application Number | M020 | ||||||||||||
| Labeler Name | ISDIN Corp | ||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide 11%
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 15 minutes before sun exposure During sun exposure, reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures: Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.- 2 p.m. wear long- sleeve shirts, pants, hats and sunglasses Children under 6 months: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Diethylhexyl Carbonate, Dibutyl Adipate, Cyclopentasiloxane, Dicaprylyl Carbonate, Alcohol Denat., Cyclohexasiloxane, Butylene Glycol, PEG-30 Dipolyhydroxystearate, Nylon-12, PEG-10 Dimethicone, Dimethicone, Sodium Chloride, Phenoxyethanol, Disteardimonium Hectorite, Triethoxycaprylylsilane, Tocopheryl Acetate, Glyceryl Stearate, Fragrance, Bisabolol, Disodium EDTA, Ethylhexylglycerin, Panthenol, PEG-8, Tocopherol, Lecithin, Plankton Extract, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid.
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 Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun
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.Eryfotona Actinica Ultralight Emulsion Sunscreen ZINC OXIDE ZINC OXIDE LECITHIN, SOYBEAN WATER DIETHYLHEXYL CARBONATE Dibutyl Adipate CYCLOMETHICONE 5 Dicaprylyl Carbonate Alcohol DENATONIUM BENZOATE CYCLOMETHICONE 6 Butylene Glycol PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) Nylon-12 PEG-10 DIMETHICONE (600 CST) Dimethicone Sodium Chloride Phenoxyethanol Disteardimonium Hectorite Triethoxycaprylylsilane .ALPHA.-TOCOPHEROL ACETATE GLYCERYL MONOSTEARATE LEVOMENOL EDETATE DISODIUM ANHYDROUS Ethylhexylglycerin Panthenol POLYETHYLENE GLYCOL 400 Tocopherol Ascorbyl Palmitate Ascorbic Acid CITRIC ACID MONOHYDRATE ANACYSTIS NIDULANS
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.PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton ISDIN PHOTO Eryfotona Actinica ® Ultralight Emulsion BROAD SPECTRUM SPF 50+ Designed for Actinic Damage Sunscreen with DNA Repairsomes™ and antioxidants. Water resistant (40 minutes) 100% MINERAL SUNSCREEN 3.4 FL OZ (100 mL) Principal Display Panel - 100 mL Bottle Carton
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
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call (862) 242-8129 Monday – Friday (9 a.m. to 5 p.m. EST) or visit www.isdin/us USA Patent Pending
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 doctor if 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect the product in this container from excessive heat and direct sun.
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.Warning 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 doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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