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Product NDC Code | 68062-9100 | ||||
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Drug Name | Pharmaskincare solar-c moisturizer spf 15 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | part352 | ||||
Labeler Name | Spa de Soleil | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 5.3%
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 every morning as a daily moisturizer. Apply generously and evenly 15 minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under six months of age: consult a doctor before use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Titanium Dioxide, Polyglyceryl-3 Beeswax, Polyglyceryl-6 Distearate, Jojoba Esters, Polyhydroxystearic Acid, Carbomer, *CO Glycerin, Sodium Hydroxide, Thymus Vulgaris (Thyme) Leaf Extract, Rosa Canina Fruit Extract, Gardenia Florida Fruit Extract, Fucus Vesiculosus Extract, *CO Carum Petroselinum (Parsley) Extract, *CO Centella Asiatica Leaf Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Daucus Carota Sativa (Carrot) Root Extract, *CO Euphrasia Officinalis Extract, Benzyl Alcohol, Disodium EDTA, Dehydroacetic Acid
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. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Sun Alert) decreases the risk of skin cancer and early skin aging caused by the sun. Sun Alert: Spending time in the use 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 such as limited time in the sun, especially from 10 a.m. to 2 p.m. Wear long pants, hats, sunglasses, and long-sleeve shirts.
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.Pharmaskincare Solar-C Moisturizer SPF 15 zinc oxide MEDIUM-CHAIN TRIGLYCERIDES ZINC OXIDE ZINC OXIDE WATER COCONUT OIL SAFFLOWER OIL CETYL ALCOHOL GLYCERIN
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.Pharmaskincare SolarC SPF 15 Pharmaskincare SolarC SPF 15
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.Warning Keep out of reach of children.
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.
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 broken or damaged skin When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor is rash or irritation occurs or lasts. If swallowed, seek medical help or contact a poison control center right away. Keep out of reach of children.
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