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| Product NDC Code | 66163-1000 | ||||
|---|---|---|---|---|---|
| Drug Name | Norwex natural sunscreen broad spectrum spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| Application Number | part352 | ||||
| Labeler Name | Cosmetic Solutions LLC | ||||
| 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.MEDICINAL INGREDIENT MEDICINAL % W/W– P/P 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 Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours or after 80 minutes of swimming or sweating and immediately after towel drying. For use on children under 6 months of age, consult doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.NON-MEDICINAL INGREDIENTS Helianthus Annuus (Sunflower) Seed Oil, Cera Alba (Beeswax), Ricinus Communis (Castor) Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Tocopherols.
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.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 broad spectrum SPF 15 or higher, limit time in the sun (especially from 10 a.m.-2 p.m.), and wear long-sleeved shirts, pants, hats, and sunglasses.
Purpose
Information about the drug product’s indications for use.MEDICINAL INGREDIENT MEDICINAL % W/W– P/P Zinc Oxide 20%
Spl product data elements
Usually a list of ingredients in a drug product.Norwex Natural Sunscreen Broad Spectrum SPF 30 Zinc Oxide Zinc Oxide Zinc Oxide CASTOR OIL JOJOBA OIL TOCOPHEROL COCONUT OIL OLIVE OIL SHEA BUTTER WHITE WAX SUNFLOWER OIL
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 - 85 g Tube Label NATURAL SUNSCREEN EVERYDAY 30 Broad Spectrum SPF 30 (UVA/UVB) Water Resistant (80 min) Non-Nano Dermatologist Tested Norwex ® NPN 80091604 85 g / 3 oz. NET PRINCIPAL DISPLAY PANEL - 85 g Tube Label
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.MANUFACTURED BY : PLS (Taos, New Mexico, USA) | DISTRIBUTED BY : Norwex Canada, Inc., Dauphin, MB R7N 3B3
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. Store at 15-30C. Do not use if safety seal is broken. 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. Do not use on damaged/broken skin or if allergic to any of the ingredients. When using this product avoid contact with eyes. If contact occurs, rinse throughly with water. Stop use and consult a doctor if rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Store at 15-30C. Do not use if safety seal is broken. May stain some fabrics.
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