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Product NDC Code | 72043-4341 | ||||
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Drug Name | Elta md |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SPRAY | ||||
Application Number | M020 | ||||
Labeler Name | CP Skin Health Group, Inc. | ||||
Packages |
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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.Apply liberally 15 minutes before sun exposure Reapply: after 80 minutes of swimming or sweating: immediately after towel drying: at lear every 2 hours Sun Protection Measures Spending time in the sun can increase your riske of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF 15 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-sleeve shirts, pants, hats, and sunglasses Children under 6 months:Ask a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Caprylic/Capric Triglyceride, Helianthys Annuus (Sunflower) Seed Wax, Cerearyl Nonanoate, Theobroma Cacao Cocoa) Seed Butter, Butyloctyl Salicylate, Lauryl Laurate, Polyhydroxystearic Acid, Euphorbia Cerifera (Candelilla) Was, Capryloyl Glycerin/Sebacic Acid Copolymer, Mica, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Oryzanol, Ethyl Ferulate, Isostearic Acid, Lecithin, Polyglyceryl-3 Plyricinoleate, Bisabolol, Tocopherol, Silica
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 (seeDirections), decreases the risk of UV damage and early skin aging caused by the sun
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Elta MD Zinc Oxide ZINC OXIDE ZINC OXIDE WATER
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.Elta MD UV Active Spray UV Active Spray
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.If product is swallowed, get medical help or contact a Poison Control Center right away.
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 ask a physician if rash occurs
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