NDC 58668-2631 Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 103

Titanium Dioxide

NDC Product Code 58668-2631

NDC CODE: 58668-2631

Proprietary Name: Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 103 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: 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

  • 58668 - Laboratoires Clarins S.a.
    • 58668-2631 - Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 103

NDC 58668-2631-1

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

NDC Product Information

Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 103 with NDC 58668-2631 is a a human over the counter drug product labeled by Laboratoires Clarins S.a.. The generic name of Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 103 is titanium dioxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Laboratoires Clarins S.a.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 103 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 18.9 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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • ALCOHOL (UNII: 3K9958V90M)
  • HEXAMETHYLENE DIISOCYANATE (UNII: 0I70A3I1UF)
  • PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
  • NYLON-12 (UNII: 446U8J075B)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • MICA (UNII: V8A1AW0880)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
  • SORBIC ACID (UNII: X045WJ989B)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • ASPARAGOPSIS ARMATA (UNII: 2936KN6I1G)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
  • SODIUM ALGINATE (UNII: C269C4G2ZQ)
  • ACACIA (UNII: 5C5403N26O)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • 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: Laboratoires Clarins S.a.
Labeler Code: 58668
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: 07-03-2013 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 - NO 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".

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Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 103 Product Label Images

Clarins Skin Illusion Spf 10 Natural Radiance Foundation Tint 103 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 Ingredient

TITANIUM DIOXIDE 1.89%

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn

Warnings:

Skin Cancer / Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Apply liberally 15 minutes before sun exposureapply to all skin exposed to the sunchildren under 6 months: Ask a doctorreapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweating.

Inactive Ingredients

AQUA/WATER/EAU . CYCLOPENTASILOXANE . ISONONYL ISONONANOATE . BUTYLENE GLYCOL . ALCOHOL . HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER . PEG/PPG-20/15 DIMETHICONE . NYLON-12 . MAGNESIUM SULFATE . POLYGLYCERYL 3 DIISOSTEARATE . SILICA . DISTEARDIMONIUM HECTORITE . POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE . PEG-10 DIMETHICONE . PARFUM/ FRAGRANCE . GLYCERIN . ALUMINUM HYDROXIDE . STEARIC ACID . DISODIUM STEAROYL GLUTAMATE . ETHYLHEXYLGLYCERIN . METHYLPROPANEDIOL . MICA . DISODIUM EDTA . HYDROXYETHYL UREA . SORBIC ACID . HYDRATED SILICA . ASPARAGOPSIS ARMATA EXTRACT . CAMELLIA SINENSIS LEAF EXTRACT . PHENOXYETHANOL . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . ALGIN . ACACIA SENEGAL GUM . OPAL POWDER . CARBOMER. ± / MAY CONTAIN/PEUT CONTENIR: CI 77891/TITANIUM DIOXIDE . CI 77491/CI 77492/CI 77499/IRON OXIDES. [M2067A]

Other Information:

  • Protect this product from excessive heat and direct sun.

Www.Clarins.Com

A light-reflecting, hydrating foundation that perfectly combines mineral and plant ingredients to create a naturally radiant complexion. The unique blend of ingredients continuously hydrates and protects the skin resulting in an incredibly comfortable, beautifully radiant and perfectly even complexion. Satin finish - Medium coverage - All skin types.Non-comedogenic. Dermatologist tested.Oil-free.CLARINS-PARIS92200 Neuilly95300 Pontoise - FranceMade in FranceBrevet (WO), marques et modele deposesPatent application (WO)18M  ref. 402631

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