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| Product NDC Code | 13630-0271 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | No-ad broad spectrum spf 50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | AEROSOL | ||||||||
| 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 5%
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 • Shake well. Spray liberally and spread evenly by hand 15 minutes before sun exposure • 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 and avoid inhalation • Children under 6 months of age: ask a doctor • Reapply: •after 80 minutes of swimming or sweating. •Immediately after towel drying. •at least every 2 hours. • 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 value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 am - 2 pm • Wear long-sleeved shirts, pants, hats and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer
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.NO-AD Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene ALCOHOL VINYL ACETATE ISOBORNYL ACRYLATE MONOBUTYL MALEATE .ALPHA.-TOCOPHEROL ACETATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE AVOBENZONE AVOBENZONE Colorless to 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.NO-AD SPF 50 Sport Sunscreen Spray 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 • Store between 20° and 25°C (68° to 77°F) • May stain some fabrics/materials or surfaces
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor • if rash or irritation develops and lasts.
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.
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. • keep away from face to avoid breathing it.
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. Contents under pressure. Do not puncture or incinerate. Do not sotre at temperatures above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. Do not use on damaged or broken skin When using this product • keep out of eyes. Rinse with water to remove. • keep away from face to avoid breathing it. Stop use and ask a doctor • if rash or irritation develops and lasts. 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