NDC 49817-2040 Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey

Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey with NDC 49817-2040 is a a human over the counter drug product labeled by Guerlain. The generic name of Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey is titanium dioxide. The product's dosage form is emulsion and is administered via topical form.

Labeler Name: Guerlain

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey 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.

• TITANIUM DIOXIDE 17.6 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

• WATER (UNII: 059QF0KO0R)
• GLYCERIN (UNII: PDC6A3C0OX)
• PROPANEDIOL (UNII: 5965N8W85T)
• SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
• C15-19 ALKANE (UNII: CI87N1IM01)
• DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
• POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
• COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
• DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
• SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
• .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
• SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
• STEARIC ACID (UNII: 4ELV7Z65AP)
• SODIUM CITRATE (UNII: 1Q73Q2JULR)
• XANTHAN GUM (UNII: TTV12P4NEE)
• ALUMINUM OXIDE (UNII: LMI26O6933)
• POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
• CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
• BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
• ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
• MALTODEXTRIN (UNII: 7CVR7L4A2D)
• TOCOPHEROL (UNII: R0ZB2556P8)
• COCOA (UNII: D9108TZ9KG)

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: Guerlain
Labeler Code: 49817
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: 03-09-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
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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