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| Product NDC Code | 66163-1001 | ||||
|---|---|---|---|---|---|
| Drug Name | Norwex natural sunscreen lip balm broad spectrum spf 15 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| 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.Active Ingredient Zinc Oxide 10.5%
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 80 minutes of swimming or sweating and immediately after towel drying. Sun Protection Measures: Use Broad Spectrum sunscreens with SPF values of 15 or higher regularly and as directed. Limit time in the sun (especially between 10 a.m. to 2 p.m.) when the sun's rays are most intense. Wear clothing like long-sleeved shirts, pants, sunglasses and broad-brimmed hats to cover skin exposed to the sun.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients Helianthus Annuus (Sunflower) Seed Oil, Beeswax, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor, Polyhydroxystearic Acid, Butyrospermum Parkii (Shea) Butter, Rubus Idaeus (Raspberry) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Simmondsia Chinensis (Jojoba) Seed Oil, Calophyllum Inophyllum Seed Oil
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.Norwex Natural Sunscreen Lip Balm Broad Spectrum SPF 15 Zinc Oxide Zinc Oxide Zinc Oxide COCOA BUTTER JOJOBA OIL TOCOPHEROL COCONUT OIL MEDIUM-CHAIN TRIGLYCERIDES SHEA BUTTER YELLOW WAX SUNFLOWER OIL TAMANU OIL RASPBERRY SEED OIL POLYHYDROXYSTEARIC ACID (2300 MW)
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 - 4.3 g Cylinder Label NATURAL SUNSCREEN LIP BALM EVERYDAY 15 Broad Spectrum SPF 15 (UVA/UVB) Water Resistant (80 min) Sealed for your protection 4.3 g / 0.15 oz. NET WT Principal Display Panel - 4.3 g Cylinder 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.Drug Facts
MANUFACTURED BY: PLS (Taos, New Mexico, USA) | DISTRIBUTED BY: Norwex USA Inc., Coppell, TX, 75019
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, contact poison control center or get medical help immediately. Consult a health care professional before applying sunscreen to infants younger than 6 months.
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 Visit www.Norwex.com or call toll free 1-866-450-7499.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect the product from excessive heat and 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 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 consult a doctor if a rash occurs. Keep out of reach of children. If swallowed, contact poison control center or get medical help immediately. Consult a health care professional before applying sunscreen to infants younger than 6 months.
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