NDC 49817-0076 Terracotta Joli Teint Beautifying Foundation With Sunscreen Sun-kissed, Healthy Glow Broad Spectrum Spf 20 Natural

Octinoxate, Titanium Dioxide

NDC Product Code 49817-0076

NDC CODE: 49817-0076

Proprietary Name: Terracotta Joli Teint Beautifying Foundation With Sunscreen Sun-kissed, Healthy Glow Broad Spectrum Spf 20 Natural 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, 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

  • 49817 - Guerlain
    • 49817-0076 - Terracotta Joli Teint Beautifying Foundation With Sunscreen Sun-kissed, Healthy Glow Broad Spectrum Spf 20 Natural

NDC 49817-0076-1

Package Description: 30 mL in 1 TUBE

NDC Product Information

Terracotta Joli Teint Beautifying Foundation With Sunscreen Sun-kissed, Healthy Glow Broad Spectrum Spf 20 Natural with NDC 49817-0076 is a a human over the counter drug product labeled by Guerlain. The generic name of Terracotta Joli Teint Beautifying Foundation With Sunscreen Sun-kissed, Healthy Glow Broad Spectrum Spf 20 Natural is octinoxate, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Guerlain

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.

Terracotta Joli Teint Beautifying Foundation With Sunscreen Sun-kissed, Healthy Glow Broad Spectrum Spf 20 Natural 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 39.9 mg/mL
  • TITANIUM DIOXIDE 43.8 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)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • ALCOHOL (UNII: 3K9958V90M)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ISODODECANE (UNII: A8289P68Y2)
  • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • CHLORELLA VULGARIS (UNII: RYQ4R60M02)
  • DIAMOND (UNII: 6GRV67N0U2)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: 04-10-2014 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: 12-31-2021 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’.

* Please review the disclaimer below.

Terracotta Joli Teint Beautifying Foundation With Sunscreen Sun-kissed, Healthy Glow Broad Spectrum Spf 20 Natural Product Label Images

Terracotta Joli Teint Beautifying Foundation With Sunscreen Sun-kissed, Healthy Glow Broad Spectrum Spf 20 Natural 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

Octinoxate 3.99%Titanium Dioxide 4.38%

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.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.-2 p.m.Wear long-sleeved shirts, pants, hats and sunglasses.Children under 6 months: Ask a doctor.

Inactive Ingredients

AQUA (WATER) - METHYL TRIMETHICONE - ALCOHOL - DIMETHICONE - ISODODECANE - PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE - POLYMETHYLSILSESQUIOXANE - ACRYLATES/DIMETHICONE COPOLYMER - DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER - GLYCERIN - ALUMINUM HYDROXIDE - STEARIC ACID - DISTEARDIMONIUM HECTORITE - PHENOXYETHANOL - GLYCERYL UNDECYL DIMETHICONE - SODIUM MYRISTOYL GLUTAMATE - HYDROXYETHYLCELLULOSE - SODIUM CHLORIDE - PROPYLENE CARBONATE - PARFUM (FRAGRANCE) - CHLORELLA VULGARIS EXTRACT - DIAMOND POWDER - BENZYL SALICYLATE - LINALOOL - TROPAEOLUM MAJUS EXTRACT - BHT - ETHYLHEXYLGLYCERIN - TOCOPHEROL - [MAY CONTAIN: CI 77891 (TITANIUM DIOXIDE) - CI 77492, CI 77491, CI 77499 (IRON OXIDES)]  (08216)

Other Information

  • Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.