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| Product NDC Code | 54473-163 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sun shades sport sport plus |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Melaleuca, 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 15%, Octisalate 5%, Octocrylene 10%
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 before first use apply evenly and liberally to all exposed areas before sun exposure do not spray directly on face. Spray on hands to apply to face use in well-ventilated area reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise, reapply at least every 2 hours. children under 6 months of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylates/octacrylamide copolymer, aleurites moluccana seed oil, ascorbyl palmitate, bisabolol, bixa orellana seed extract, C12-15 alkyl benzoate, caprylic/capric triglyceride, disodium lauriminodipropionate tocopheryl phosphate, macadamia ternifolia seed oil, parfum, phenyl trimethicone, polyester-10, propylene glycol dibenzoate, SD alcohol 40-B, tocopherol
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.Sun Shades Sport Sport Plus Avobenzone, Homosalate, Octisalate, and Octocrylene ALCOHOL ALPHA-TOCOPHEROL ACETATE ASCORBYL PALMITATE BIXA ORELLANA SEED ALKYL (C12-15) BENZOATE KUKUI NUT OIL LEVOMENOL MACADAMIA OIL PHENYL TRIMETHICONE PROPYLENE GLYCOL DIBENZOATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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.image of label
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 right away.
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 or irritation develops and lasts
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. do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
Storage and handling
Information about safe storage and handling of the drug product.Other information do not store at temperatures below 32°F (0°C) or above 120°F (49°C)
General precautions
Information about any special care to be exercised for safe and effective use of the drug.Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun may stain some fabrics
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
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