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Avene cleanance mattifying spf 30 - Medication Information

Product NDC Code 64760-786
Drug Name

Avene cleanance mattifying spf 30

Type Brand
Active Ingredients
Zinc oxide 100 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Pierre Fabre USA Inc.
Packages
Package NDC Code Description
64760-786-01 1 tube in 1 carton (64760-786-01) / 50 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc oxide 10%

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: • Shake well • Apply generously 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating • 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, C12-15 Alkyl Benzoate, Jojoba Esters, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Caprylic/Capric Triglyceride, Propanediol, Tridecyl Salicylate, Methylheptyl Isostearate, Kaolin, Niacinamide, Methylpropanediol, Glycerin, Coco-Caprylate, Silica, Sodium Chloride, Oryza Sativa (Rice) Bran Extract, Caprylyl Glycol, Bisabolol, Allantoin, Lecithin, Helianthus Annuus (Sunflower) Extract, Phenylpropanol, Maltodextrin, Tocopherol, Lactobacillus, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tetrasodium Glutamate Diacetate, Chlorophyllin Copper Complex, Tremella Fuciformis Sporocarp Extract, 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.
Uses • Helps prevent sunburn

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 Cleanance Mattifying SPF 30 Zinc oxide WATER ALKYL (C12-15) BENZOATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE RICE BRAN BIFIDOBACTERIUM ANIMALIS LACTIS TREMELLA FUCIFORMIS FRUITING BODY ALLANTOIN TETRASODIUM GLUTAMATE DIACETATE ZINC OXIDE ZINC OXIDE PROPANEDIOL TRIDECYL SALICYLATE METHYLPROPANEDIOL SODIUM CHLORIDE SODIUM HYDROXIDE METHYLHEPTYL ISOSTEARATE JOJOBA OIL, RANDOMIZED NIACINAMIDE COCO-CAPRYLATE MEDIUM-CHAIN TRIGLYCERIDES KAOLIN GLYCERIN SILICON DIOXIDE CAPRYLYL GLYCOL LEVOMENOL LECITHIN, SOYBEAN MALTODEXTRIN TOCOPHEROL ROSEMARY SODIUM COPPER CHLOROPHYLLIN HELIANTHUS ANNUUS FLOWERING TOP PHENYLPROPANOL

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 337110 Box 337110

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 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 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? 1-877-441-2011 (CAN) 1-866-41-AVENE (28363)(USA)

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