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

Product Information

What is NDC 49817-2040?

The NDC code 49817-2040 is assigned by the FDA to the product Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey which is 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. The product is distributed in 3 packages with assigned NDC codes 49817-2040-1 1 bottle in 1 box / 30 ml in 1 bottle, 49817-2040-3 1 bottle in 1 box / 15 ml in 1 bottle, 49817-2040-6 1 bottle in 1 box / .5 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code49817-2040
Proprietary Name 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.
Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey
Non-Proprietary Name 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.
Titanium Dioxide
Product Type 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.
Human Otc Drug
Dosage FormEmulsion - 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.)
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.
Guerlain
Labeler Code49817
FDA Application Number 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.
part352
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-09-2019
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey?


Product Packages

NDC Code 49817-2040-1

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

NDC Code 49817-2040-3

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

NDC Code 49817-2040-6

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

Product Details

What are Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey Active Ingredients UNII Codes

Lessentiel Natural Glow Foundation 16h Wear With Sunscreen Broad Spectrum Spf 20 05n Miel/honey Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

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

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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.

Question Or Comments?



In USA: 19 East, 57th Street, New York, NY 10022 855 454 6242 Monday through Friday 9am to 5pm EST.


L’Essentiel Natural Glow Foundation 16H Wear With Sunscreen Broad Spectrum Spf 20 05N Miel/Honey, 15Ml (49817-2040-3)




L’Essentiel Natural Glow Foundation 16H Wear With Sunscreen Broad Spectrum Spf 20 05N Miel/Honey, 30Ml (49817-2040-1)




L’Essentiel Natural Glow Foundation 16H Wear With Sunscreen Broad Spectrum Spf 20 05N Miel/Honey, 0.5Ml (49817-2040-6)




* Please review the disclaimer below.