NDC 49817-2038 Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 04n Moyen/medium

Titanium Dioxide

NDC Product Code 49817-2038

NDC Code: 49817-2038

Proprietary Name: Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 04n Moyen/medium Additional informationCallout TooltipWhat 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: Titanium Dioxide Additional informationCallout TooltipWhat 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.


Code Structure
  • 49817 - Guerlain
    • 49817-2038 - Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20

NDC 49817-2038-1

Package Description: 1 BOTTLE in 1 BOX > 30 mL in 1 BOTTLE

NDC 49817-2038-3

Package Description: 1 BOTTLE in 1 BOX > 15 mL in 1 BOTTLE

NDC 49817-2038-6

Package Description: 1 BOTTLE in 1 BOX > .5 mL in 1 BOTTLE

NDC Product Information

Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 04n Moyen/medium with NDC 49817-2038 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 04n Moyen/medium 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 Additional informationCallout TooltipWhat 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 04n Moyen/medium Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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’.

* Please review the disclaimer below.

Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 04n Moyen/medium Product Label Images

Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 04n Moyen/medium 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

Titanium dioxide 1.76%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For sunscreen use:Apply liberally 15 minutes before sun exposure.Reapply at least every two hours.Use a water resistant sunscreen if swimming or sweating.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.-2 p.m.Wear long-sleeved shirts, pants, hats, and sunglasses.Children under 6 months: Ask a doctor.

Inactive Ingredients

AQUA (WATER) ● C9-12 ALKANE ● GLYCERIN ● PROPANEDIOL ● POLYGLYCERYL-6 POLYRICINOLEATE ● SILICA ● C15-19 ALKANE ● VP /EICOSENE COPOLYMER ● DICAPRYLYL CARBONATE ● POLYGLYCERYL-2 ISOSTEARATE ● COCO-CAPRYLATE/CAPRATE ● DISTEARDIMONIUM HECTORITE ● SORBITAN SESQUIISOSTEARATE ● PARFUM (FRAGRANCE) ● CAESALPINIA SPINOSA FRUIT EXTRACT ● ALPHA-GLUCAN OLIGOSACCHARIDE ● SODIUM MYRISTOYL GLUTAMATE ● STEARIC ACID ● SODIUM CITRATE ● XANTHAN GUM ● ALUMINA ● POLYHYDROXYSTEARIC ACID ● CELLULOSE ● POTASSIUM SORBATE ● KAPPAPHYCUS ALVAREZII EXTRACT ● POLYMNIA SONCHIFOLIA ROOT JUICE ● CITRIC ACID ● BUTYLENE GLYCOL ● ALUMINUM HYDROXIDE ● MALTODEXTRIN ● LACTOBACILLUS ● TOCOPHEROL ● THEOBROMA CACAO (COCOA) SEED EXTRACT ● [MAY CONTAIN : CI 77491, CI 77492, CI 77499 (IRON OXIDES) ● CI 77891 (TITANIUM DIOXIDE) ● CI 77947 (ZINC OXIDE)]

Other Information

  • Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.

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