NDC 67015-0033 Eau Thermale Avene Hydrance Optimale Hydrating Broad Spectrum Spf 25

Octinoxate, Octocrylene, Titanium Dioxide

NDC Product Code 67015-0033

NDC CODE: 67015-0033

Proprietary Name: Eau Thermale Avene Hydrance Optimale Hydrating Broad Spectrum Spf 25 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Octinoxate, Octocrylene, Titanium Dioxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 67015 - Pierre Fabre Dermo-cosmetique Usa, Inc.
    • 67015-0033 - Eau Thermale Avene Hydrance Optimale Hydrating Broad Spectrum Spf 25

NDC 67015-0033-0

Package Description: 1 TUBE in 1 CARTON > 40 mL in 1 TUBE

NDC Product Information

Eau Thermale Avene Hydrance Optimale Hydrating Broad Spectrum Spf 25 with NDC 67015-0033 is a a human over the counter drug product labeled by Pierre Fabre Dermo-cosmetique Usa, Inc.. The generic name of Eau Thermale Avene Hydrance Optimale Hydrating Broad Spectrum Spf 25 is octinoxate, octocrylene, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pierre Fabre Dermo-cosmetique Usa, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Eau Thermale Avene Hydrance Optimale Hydrating Broad Spectrum Spf 25 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTINOXATE 75 mg/mL
  • OCTOCRYLENE 80 mg/mL
  • TITANIUM DIOXIDE 32 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pierre Fabre Dermo-cosmetique Usa, Inc.
Labeler Code: 67015
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-16-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 04-30-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Eau Thermale Avene Hydrance Optimale Hydrating Broad Spectrum Spf 25 Product Label Images

Eau Thermale Avene Hydrance Optimale Hydrating Broad Spectrum Spf 25 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

OCTOCRYLENE 8%OCTINOXATE 7.5%TITANIUM DIOXIDE 3.2%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (see Directions) decreases the risk if skin cancer and early skin aging caused by the sun.

Warnings

  • For external use onlyDo not use on damaged or broken skinWhen 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.

Directions

  • Apply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweating.Reapply: 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 skin protection measures including:limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglassesChildren under 6 months: Ask a doctor

Inactive Ingredients

WATER/EAU (AQUA), CYCLOMETHUCONE, GLYCERIN, ETHYLHEXYL PALMITATE, STEARLY ALCOHOL, POTASSIUM CETYL PHOSPHATE, GLYCERYL STEARATE ALUMINA, BENZOIC ACID, BETA.SITOSTEROL, BHT, CAPRYLIC/CAPRIC TRIGYLCERIDE, CHLORPHENESIN, DISODIUM EDTA, GLYCINE SOJA (SOYBEAN) SEED EXTRACT ( GLYCINE sOJA), HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYDIMETHYL TAURATE COPOLYMER, PHENOXYETHANOL, PEG-32 PEG-400 PLOXAMER 188, POLYSORBATE 60, SIMETHICONE, SODIUM CHONDROITIN, SULFATE, SORBITAN ISOSTEARATE, SQUALANE, TOCOPHERYL GLUCOSIDE, XANTHAN GUM.

Other Information

Protect this product from excessive heat and direct sun.

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