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| Product NDC Code | 64760-782 | ||||
|---|---|---|---|---|---|
| Drug Name | Avene face sunscreen spf 50 |
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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.Directions Adults and children 6 months and older: • Apply generously 15 minutes before sun exposure • Reapply: • at least every 2 hours • after 80 minutes of swimming or sweating • immediately after towel drying • Children under 6 months of age: Ask a doctor • 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 value 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water/Eau/Aqua, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Tridecyl Salicylate, Polyglyceryl-3 Polyricinoleate, Glyceryl Stearate, Shea Butter Ethyl Esters, Sodium Chloride, Polyester-7, Silica, Neopentyl Glycol Diheptanoate, Isoamyl Laurate, Polyglyceryl-2 Dipolyhydroxystearate, Glyceryl Dibehenate, Bisabolol, Phenylpropanol, Iron Oxides, Propanediol, Lecithin, Tribehenin, Allantoin, Caprylyl Glycol,Glyceryl Behenate, Coco-Caprylate, Tocopheryl Acetate, Tetrasodium Glutamate Diacetate, Polyglyceryl-4 Diisostearate/ Polyhydroxystearate/Sebacate, Hydrogenated Lecithin, Sodium Hydroxide, Tocopherol.
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 skin cancer 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.Avene Face Sunscreen SPF 50 Zinc oxide MEDIUM-CHAIN TRIGLYCERIDES ALKYL (C12-15) BENZOATE GLYCERYL MONOSTEARATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE LEVOMENOL PHENYLPROPANOL ALLANTOIN CAPRYLYL GLYCOL GLYCERYL MONOBEHENATE COCO-CAPRYLATE TETRASODIUM GLUTAMATE DIACETATE WATER TRIDECYL SALICYLATE HYDROGENATED SOYBEAN LECITHIN TOCOPHEROL ZINC OXIDE ZINC OXIDE SODIUM CHLORIDE POLYESTER-7 ISOAMYL LAURATE GLYCERYL DIBEHENATE FERRIC OXIDE RED PROPANEDIOL LECITHIN, SOYBEAN POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE SILICON DIOXIDE TRIBEHENIN SODIUM HYDROXIDE GLYCERIN POLYGLYCERYL-3 PENTARICINOLEATE SHEA BUTTER ETHYL ESTERS NEOPENTYL GLYCOL DIHEPTANOATE ALPHA-TOCOPHEROL ACETATE
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.Box 337120 Box 337120
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
Other information • Protect the product in this container from excessive heat and direct sun.
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 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 swallowed, call a poison control center or get medical help 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? 1-866-41-AVENE (28363) 1-877-441-2011 (CAN)
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.
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