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| Product NDC Code | 64760-725 | ||||
|---|---|---|---|---|---|
| Drug Name | Avene solaire uv tinted 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 WATER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, JOJOBA ESTERS, TRIDECYL SALICYLATE, METHYLHEPTYL ISOSTEARATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, NIACINAMIDE, NYLON-12, METHYLPROPANEDIOL, COCO-CAPRYLATE, IRON OXIDES, SILICA, AVENE THERMAL SPRING WATER, 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, HYDROGENATED LECITHIN,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 40 minutes of swimming or sweating • immediately after towel drying • 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, 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 Tinted Mineral Sunscreen SPF 50 PLUS Zinc Oxide POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE RICE BRAN OIL TETRASODIUM GLUTAMATE DIACETATE WATER ROSEMARY LEVOMENOL METHYLHEPTYL ISOSTEARATE NYLON-12 FERRIC OXIDE YELLOW ALKYL (C12-15) BENZOATE NIACINAMIDE ALLANTOIN PHENYLPROPANOL HELIANTHUS ANNUUS FLOWERING TOP TOCOPHEROL ISOSTEARIC ACID LECITHIN, SOYBEAN 1,2-HEXANEDIOL SODIUM HYDROXIDE CAPRYLYL GLYCOL FERROSOFERRIC OXIDE HYDROGENATED SOYBEAN LECITHIN FERRIC OXIDE RED SILICON DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES PROPANEDIOL JOJOBA OIL TRIDECYL SALICYLATE ZINC OXIDE ZINC OXIDE METHYLPROPANEDIOL COCO-CAPRYLATE SODIUM CHLORIDE
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+ UVA/UVB Broad Spectrum SPF 50+ Solaire UV Mineral Multi-Defense Tinted Sunscreen Fluid Fragrance-Free • Oil-Free Water Resistant (40-Minute) Sheer, Natural Finish Sensitive Skin 50 ml/1.7 FL. OZ. Pierre Fabre Dermo-Cosmetique Laboratoires Dermatologiques Avène 45, place Abel-Gance 92100 Boulogne - Paris - France Les Cauquillous - 81500 Lavaur - France Distributed by: Pierre Fabre USA Inc Parsippany, NJ 07054 label
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.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information • Protect this product from excessive heat and direct sun.
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