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| Product NDC Code | 61649-110 | ||||
|---|---|---|---|---|---|
| Drug Name | Bio spectra attitude |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | 9055-7588 Quebec Inc. DBA Attitude | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc oxide (20%)
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 Adults and children older than 6 months. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive or non-medicinal ingredients Aqua / Water / Eau, Caprylic/Capric Triglyceride, Cetearyl Glucoside, Glyceryl Stearate, Cetearyl Alcohol, Polyhydroxystearic Acid, C10-18 Triglycerides, Glycerin, Ethylhexylglycerin, Caprylyl Glycol, Behenyl Alcohol, Sodium Chloride, Xanthan Gum, Sodium Gluconate.
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.BIO SPECTRA ATTITUDE ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES POLYHYDROXYSTEARIC ACID (2300 MW) CETOSTEARYL ALCOHOL GLYCERYL MONOSTEARATE CETEARYL GLUCOSIDE ETHYLHEXYLGLYCERIN GLYCERIN C10-18 TRIGLYCERIDES DOCOSANOL SODIUM CHLORIDE XANTHAN GUM CAPRYLYL GLYCOL SODIUM GLUCONATE ZINC OXIDE ZINC OXIDE Opaque
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 - 150 g Tube Label ATTITUDE ® natural care SPF 30 Unscented Mineral sunscreen Broad spectrum SPF 30 UVA/UVB - Non nano SUNLY VEGAN Dermatologically tested EWG Verified NPN 80047088 • 150 g e / 5.2 OZ. Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and administration : update of the Directions
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
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 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 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 ? 1-855-509-7225
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 consult 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 avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at temperatures below 90°F and protect from direct sun.
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 Allergens: soybeans (glycerin). For external use only. Do not use on broken skin. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and consult a 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