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Product NDC Code | 72043-0495 | ||||
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Drug Name | Elta md skincare uv stick broad spectrum spf50 |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | STICK | ||||
Application Number | part352 | ||||
Labeler Name | CP Skin Health Group, Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Zinc Oxide 22.0% Purpose Sunscreen
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 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 (see Directions ), decreases the risk of UV damage and early skin aging caused by the sun
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.Elta MD Skincare UV Stick Broad Spectrum SPF50 Zinc Oxide MEDIUM-CHAIN TRIGLYCERIDES HELIANTHUS ANNUUS SEED WAX CETEARYL NONANOATE COCOA BUTTER BUTYLOCTYL SALICYLATE LAURYL LAURATE POLYHYDROXYSTEARIC ACID (2300 MW) CANDELILLA WAX CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) MICA BEHENYL BEHENATE SHEA BUTTER ORYZANOL ETHYL FERULATE ISOSTEARIC ACID LECITHIN, SOYBEAN POLYGLYCERYL-3 PENTARICINOLEATE LEVOMENOL TOCOPHEROL SILICON DIOXIDE ZINC OXIDE ZINC CATION
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® Skincare UV STICK BROAD-SPECTRUM SPF 50+ net wt 1.3oz (37 g) UVstickCtn
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 When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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 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
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 physician if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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. Stop use and ask a physician if rash occurs Keep out of reach of children. If product is 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