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| Product NDC Code | 64760-724 | ||||
|---|---|---|---|---|---|
| Drug Name | Avene solaire uv mineral sunscreen spf 50 plus |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Pierre Fabre USA Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 12%
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.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients AVÈNE THERMAL SPRING WATER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, JOJOBA ESTERS, TRIDECYL SALICYLATE, METHYLHEPTYL ISOSTEARATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, NYLON-12, NIACINAMIDE, METHYLPROPANEDIOL, COCO-CAPRYLATE, SILICA, SODIUM CHLORIDE, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, CAPRYLYL GLYCOL, BISABOLOL, ALLANTOIN, ORYZA SATIVA (RICE) BRAN EXTRACT, LECITHIN, PHENYLPROPANOL, HELIANTHUS ANNUUS (SUNFLOWER) EXTRACT, TOCOPHEROL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, TETRASODIUM GLUTAMATE DIACETATE, ISOSTEARIC ACID, 1,2-HEXANEDIOL, SODIUM HYDROXIDE
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.Directions Shake well before use. Apply liberally 15 minutes before sun exposure. Reapply. After 80 minutes of swimming or sweating. Immediately after towel dry. At least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of skin cancer and early skin gaining. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m to 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.
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.Avene Solaire UV Mineral Sunscreen SPF 50 PLUS Zinc Oxide ROSEMARY OIL LEVOMENOL TRIDECYL SALICYLATE SILICON DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES NIACINAMIDE TETRASODIUM GLUTAMATE DIACETATE 1,2-HEXANEDIOL PROPANEDIOL SODIUM CHLORIDE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE CAPRYLYL GLYCOL ISOSTEARIC ACID SODIUM HYDROXIDE JOJOBA OIL METHYLHEPTYL ISOSTEARATE NYLON-12 METHYLPROPANEDIOL COCO-CAPRYLATE ZINC OXIDE ZINC OXIDE WATER ALKYL (C12-15) BENZOATE ALLANTOIN RICE BRAN OIL LECITHIN, SUNFLOWER PHENYLPROPANOL HELIANTHUS ANNUUS WHOLE TOCOPHEROL
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 - 50 mL Carton EAU THERMALE Avene SPF 50+ Broad Spectrum Solaire UV Mineral Multi-Defense Sunscreen Fluid Fragrance-Free Oil-Free 40-Minute Water Resistance Sheer, Non-Whitening For Sensitive Skin 50 ml/1.7 FL. OZ. Avene Multi Defense Sunscreen Fluid Carton 50ml
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? visit www.aveneusa.com or call toll-free 1-866-41-AVENE (28363)
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. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor 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