NDC 58668-9913 Clarins Everlasting Cushion Long-wearing And Hydrating Foundation Broad Spectrum Spf 50 Tint 105 Tester Refill With Sponge

Titanium Dioxide

NDC Product Code 58668-9913

NDC CODE: 58668-9913

Proprietary Name: Clarins Everlasting Cushion Long-wearing And Hydrating Foundation Broad Spectrum Spf 50 Tint 105 Tester Refill With Sponge 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
    • 58668-9913 - Clarins Everlasting Cushion Long-wearing And Hydrating Foundation Broad Spectrum Spf 50 Tint 105

NDC 58668-9913-1

Package Description: 13 mL in 1 CASE

NDC Product Information

Clarins Everlasting Cushion Long-wearing And Hydrating Foundation Broad Spectrum Spf 50 Tint 105 Tester Refill With Sponge with NDC 58668-9913 is a a human over the counter drug product labeled by Laboratoires Clarins. The generic name of Clarins Everlasting Cushion Long-wearing And Hydrating Foundation Broad Spectrum Spf 50 Tint 105 Tester Refill With Sponge is titanium dioxide. The product's dosage form is emulsion and is administered via topical form.

Labeler Name: Laboratoires Clarins

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.

Clarins Everlasting Cushion Long-wearing And Hydrating Foundation Broad Spectrum Spf 50 Tint 105 Tester Refill With Sponge 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 62 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)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)
  • TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ENSULIZOLE (UNII: 9YQ9DI1W42)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • NYLON-12 (UNII: 446U8J075B)
  • PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ZINC STEARATE (UNII: H92E6QA4FV)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • ADENOSINE (UNII: K72T3FS567)
  • PALMITOYL PROLINE (UNII: I49727TDYF)
  • CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
  • MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)
  • SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)
  • CERAMIDE NP (UNII: 4370DF050B)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • LAPSANA COMMUNIS FLOWERING TOP (UNII: T9B77O7PZA)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • GLYCERETH-20 (UNII: GJ57297I4F)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PEG-10 RAPESEED STEROL (UNII: 258O76T85M)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MICA (UNII: V8A1AW0880)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • 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
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: 03-08-2017 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".

* Please review the disclaimer below.

Clarins Everlasting Cushion Long-wearing And Hydrating Foundation Broad Spectrum Spf 50 Tint 105 Tester Refill With Sponge Product Label Images