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| Product NDC Code | 81493-203 | ||||
|---|---|---|---|---|---|
| Drug Name | Priia tinted mineral sunscreen and primer |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Priia Cosmetics Inc | ||||
| 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 INGREDIENTS: Titanium Dioxide 8% Zinc Oxide 3.8%
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 Immediately after towel drying At least every 2 hours Children under 6 months: 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 am-2 pm Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate
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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Priia Tinted Mineral Sunscreen and Primer Titanium Dioxide, Zinc Oxide Titanium Dioxide Titanium Dioxide Zinc Oxide Zinc Oxide Aluminum Hydroxide Cyclomethicone 6 Cyclomethicone 5 Dimethicone 20 Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) Dimethiconol (2000 CST) Brown Iron Oxide Lauryl PEG/PPG-18/18 Methicone Hydrogen Dimethicone (20 CST) PEG-10 Dimethicone (600 CST) Tetrahexyldecyl Ascorbate .Alpha.-Tocopherol Acetate
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 – 53g Bottle Label PRIIA ® minerale-derm Tinted Mineral Sunscreen + Primer SPF 40 Broad Spectrum Water Resistant (80 Minutes) Acne-Safe Net Wt. 1.8 oz/53 g Principal Display Panel – 53g Bottle Label
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 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 the reach of children . If swallowed, get medical help or contact a 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 this product from excessive heat and direct sun May stain some fabrics PA+ + + Manufactured for PRIIA ® Cosmetics, Bethlehem PA 18020 PRIIA.com
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 ask 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, 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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
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