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| Product NDC Code | 13630-0126 | ||||||||||
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| Drug Name | Miami beach sea sunscreen 30 broad spectrum spf 30 |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | SPRAY | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | Prime Packaging 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 Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 2.75% Oxybenzone 4%
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 • spray liberally and spread evenly by hand 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • inmediately after towel drying • at least every 2 hours • hold container 4 to 6 inches from the skin to apply • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in a well-ventilated area • Sun Protection Measures . Spending 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. - 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 Acrylates/Octylacrylamide Copolymer, Fragrance, Propylene Glycol, Water, Pseudopterogorgia Elisabethae Plant Extract, SD Alcohol (Alcohol Denat.).
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.Miami Beach Sea Sunscreen 30 Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone ALCOHOL PSEUDOPTEROGORGIA ELISABETHAE WATER PROPYLENE GLYCOL ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE Light Yellow
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.Miami Beach Sport Sunscreen Spray 30 Principal Display 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.Other information • protect this product from excessive heat and direct sun. • may stain fabrics.
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.Question or comments? Call 305.592.8565
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 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 eyes with water to remove. • Keep away from face to avoid breathing it. • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.
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 Flammable: Do not use near heat, flame, or while smoking. Do not use on damaged or broken skin When using this product • Keep out of eyes. Rinse eyes with water to remove. • Keep away from face to avoid breathing it. • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF. 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