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| Product NDC Code | 83105-2001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Omega-boost sheer mineral sunscreen |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | M020 | ||||||
| Labeler Name | Trilogy Natural Products Limited | ||||||
| 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 Active Ingredient: Zinc Oxide
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 generously 15 minutes before sun exposure” Reapply [bullet] after 80 minutes of swimming or sweating [bullet] immediately after towel drying [bullet] at least every 2 hours Children under 6 months of age: 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 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Coco-caprylate/caprate, polyglyceryl-3 polyricinoleate, Isostearic acid, Castor oil, Caprilic/capric triglyceride, Coconut oil, Candellila wax, Hydrogenated castor oil, Tocopherol acetate, Rosehip oil, Avocado oil, Fragrance
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 risk of skin cancer and early skin aging caused by the sun
Purpose
Information about the drug product’s indications for use.Uses Helps prevent sunburn.
Spl product data elements
Usually a list of ingredients in a drug product.Omega-Boost Sheer Mineral Sunscreen Mineral Sunscreen ZINC OXIDE ZINC OXIDE ISOSTEARIC ACID CASTOR OIL CANDELILLA WAX HYDROGENATED CASTOR OIL ROSA MOSCHATA OIL AVOCADO OIL COCO-CAPRYLATE/CAPRATE MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-TOCOPHEROL ACETATE COCONUT OIL POLYGLYCERYL-3 PENTARICINOLEATE
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.Trilogy SPF 60+ Omega-Boost Sheer Mineral Sunscreen NDC 83105-2001-0 Secondary pacakaging NDC 83105-2001-1 75 mL / 2.5 fl oz Principal Display Panel: Secondary Flat Front Outer Package
Inner Container Label NDC 83105-2001-1 75 mL Primary Container Label Inner tube label
Sample Size Package 83105-2001-2 5 mL Sample size
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 Do not use on damaged or 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 product is swallowed, get medical help or contact Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Protect the product in this container from excessive heat and direct sun. Store below 30 degrees celcius.
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 keep out of eyes. Rinse with water to remove.
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 [bullet] keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if [bullet] rash or irritation develops and lasts. Keep out of reach of children, If product is swallowed, get medical help or contact poison control centre right away. To ensure compatibility, we recommend patch testing before first use. In the unlikely event of a negative reaction, discontinue use and consult your medical practitioner.
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