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| Product NDC Code | 61481-3006 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Kinesys |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | SPRAY | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | Wilc Healthcare 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 2.5% w/w Octinoxate 7.5% w/w Octisalate 5.0% w/w Octocrylene 7.5% w/w
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 Hold container 4 to 6 inches from the skin to apply Spray generously and spread evenly by hand 15 minutes before sun exposure Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Do not spray directly onto the face. Spray into hands, and apply to the face. Do not apply in windy condition Use in 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 Bisabolol, Butyloctyl Salicylate, Cyclopentasiloxane, Diphenylsioxy Phenyl Trimethicone, Fragrance, Octyl Palmitate, Tocopherols, VP/ Hexadecene 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.Kinesys OCTINOXATE, OCTOCRYLENE, OCTISALATE, and AVOBENZONE OCTINOXATE OCTINOXATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE CYCLOMETHICONE 5 ETHYLHEXYL PALMITATE BUTYLOCTYL SALICYLATE DIPHENYLSILOXY PHENYL TRIMETHICONE VINYLPYRROLIDONE/HEXADECENE COPOLYMER TOCOPHEROL LEVOMENOL
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 - 30 mL Bottle Label NDC 61481-3006-1 BROAD SPECTRUM SPF 30 UVA+ UVB OIL FREE CLEAR SPRAY FOR ACTIVE SKIN KIN e SYS ® Performance SUNSCREEN BROAD SPECTRUM SPF 30 VANILLA-GREEN TEA 80 MINS WATER AND SWEAT RESISTANT 1.0 FL OZ (30 mL) NDC 61481-3006-4 BROAD SPECTRUM SPF 30 UVA+ UVB OIL FREE CLEAR SPRAY FOR ACTIVE SKIN KINeSYS® Performance SUNSCREEN BROAD SPECTRUM SPF 30 VANILLA-GREEN TEA 80 MINS WATER AND SWEAT RESISTANT 4.0 FL OZ (120 mL) image description image description
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
Do not use near flame or while smoking
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 toll free 1.888.KINeSYS [546.3797] www.kinesysactive.com
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 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 extreme temperatures. May stain or damage some fabrics and surfaces.
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. Do not use near 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