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Product NDC Code | 61481-3007 | ||||
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Drug Name | Kinesys pro sport lip balm with shea butter broad spectrum 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 | STICK | ||||
Application Number | M020 | ||||
Labeler Name | Wilc Healthcare Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 18%
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 8o minutes of swimming or sweating immediately after towel drying at least every 2 hours Children under 6 months, ask a doctor. 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 10am-2pm wear long sleeved shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Olea Europaea (Olive) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacoa (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter), Flavor, Tocopheryl Acetate
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
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 Pro Sport Lip Balm with Shea Butter Broad Spectrum 30 Zinc Oxide OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES WHITE WAX JOJOBA OIL COCOA BUTTER SHEA BUTTER .ALPHA.-TOCOPHEROL ACETATE 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 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 Protect this product from excessive heat and direact sun
Question or Comments? 1-888-546-3797
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 avoid contact with eyes. If contact occurs, rinse with water. Stop use and ask a doctor if rash occurs. Keep out of reach of children . If swallowed, get medical help or contact a poison control center immediately.
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