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Product NDC Code | 98132-871 | ||||
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Drug Name | Fair foundation spf 15 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | POWDER | ||||
Application Number | M020 | ||||
Labeler Name | Orveon Global US, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide 25% Zinc Oxide 19%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide, Zinc Oxide
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.Fair Foundation SPF 15 Zinc Oxide, Titanium Dioxide MICA BISMUTH OXYCHLORIDE BROWN IRON OXIDE FERRIC OXIDE YELLOW ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.Label Label continued Fair 01
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.Drug Facts
Instructions for use
Information about safe handling and use of the drug product.Directions Apply liberally 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating Reapply at least every 2 hours Sun protection measures. Spending time in the sun increases your risk of skin cancer or early skin aging. To decrease this risk, regularly use a 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 month: ask a doctor
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 1-888-795-4747
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 Skin cancer/skin aging alert: spending time in the sun increases your risk of cancer and early aging This product has been shown only to help prevent sunburn, not skin cancer or early aging For External use only Do not use on damage or broken skin When using this product keep out of eyes. Rinse with water to remove Stop use and ask doctor if rash occurs
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