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| Product NDC Code | 65435-0600 | ||||
|---|---|---|---|---|---|
| Drug Name | Safe sea spf 30 |
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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 | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Nidaria Technology Ltd. | ||||
| 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 ingredient Zinc Oxide 10.9%
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 reapply: After 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours Sun Protection MeasuresSpending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m.to 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 Benzoic Acid, Benzyl Alcohol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calcium Chloride, Caprylic / Capric triglyceride, Chlorphenisine, Dehydroacetic Acid, Dibutyl Adipate, Hydrogenated Castor Oil, Lanthanum Chloride, Magnesium Chloride, Magnesium Stearate, Panthenol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-4 Diisostearate /Polyhydroxystearate/Sebacate, Sorbic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water
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 direacted with other sun protection measures (see directions), decreases the risk of skin cancer and early aging skin 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.Safe Sea SPF 30 Zinc Oxide ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES DIBUTYL ADIPATE BUTYLOCTYL SALICYLATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE TRIETHOXYCAPRYLYLSILANE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE MAGNESIUM STEARATE HYDROGENATED CASTOR OIL PANTHENOL .ALPHA.-TOCOPHEROL ACETATE LANTHANUM CHLORIDE MAGNESIUM CHLORIDE CALCIUM CHLORIDE BENZYL ALCOHOL CHLORPHENESIN BENZOIC ACID SORBIC ACID DEHYDROACETIC ACID WATER ZINC OXIDE ZINC CATION
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.Product label image description
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.Other Information Give particular attention to coverage of arms and legs. In water infested by Sea Lice, Safe Sea should also be applied under the bathing suit. Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water, nor is it a guarantee against stings. In case of sting do not use Safe Sea as a treatment - seek medical attention.*Tested against Sea nettle (Chrysaora), Atlantic Box jellyfish (Chiropsalmus) & Rhopilema. Data on file. Protect this product 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.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 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