NDC 58668-2041 Clarins Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 114

Titanium Dioxide

NDC Product Code 58668-2041

NDC CODE: 58668-2041

Proprietary Name: Clarins Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 114 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.
    • 58668-2041 - Clarins Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 114

NDC 58668-2041-1

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

NDC Product Information

Clarins Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 114 with NDC 58668-2041 is a a human over the counter drug product labeled by Laboratoires Clarins S.a.. The generic name of Clarins Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 114 is titanium dioxide. The product's dosage form is cream and is administered via topical form.

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.

Clarins Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 114 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.


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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • TALC (UNII: 7SEV7J4R1U)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SORBIC ACID (UNII: X045WJ989B)
  • AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
  • HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • SODIUM ALGINATE (UNII: C269C4G2ZQ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • ACACIA (UNII: 5C5403N26O)
  • LAPSANA COMMUNIS WHOLE (UNII: UXH42V064J)
  • PLANTAGO MAJOR SEED (UNII: YP0NFQ834U)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)

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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-06-2010 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 Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 114 Product Label Images

Clarins Broad Spectrum Spf 15 Sunscreen Extra-firming Foundation Tint 114 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 2.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnIf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early sking aging caused by the sun

Warnings

For external use onlyDo 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.

Otc - Keep Out Of Reach Of Children

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 doctorSun 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 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.


reapply at least every 2 hours


use a water resistant sunscreen if swimming or sweating.

Inactive Ingredients

AQUA/WATER/EAU . CYCLOPENTASILOXANE  ISONONYL ISONONANOATE . BUTYLENE GLYCOL . TALC . DIMETHICONE . POLYGLYCERYL-3 RICINOLEATE . SORBITAN OLEATE . PEG-30 DIPOLYHYDROXYSTEARATE . MAGNESIUM SULFATE . SILICA . PHENOXYETHANOL . MAGNESIUM STEARATE . POLYHYDROXYSTEARIC ACID . DIMETHICONOL .  DISTEARDIMONIUM HECTORITE . DIMETHICONE  CROSSPOLYMER . PARFUM/FRAGRANCE . SORBIC ACID . AVENA SATIVA (OAT) KERNEL EXTRACT . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER . HYDROXYETHYL UREA . LAUROYL LYSINE . CAMELLIA  SINENSIS LEAF EXTRACT . ALGIN . SODIUM BENZOATE . ACACIA SENEGAL GUM . LAPSANA  COMMUNIS FLOWER/LEAF/STEM EXTRACT . PLANTAGO MAJOR SEED EXTRACT . ALPHAISOMETHYL IONONE . LINALOOL . HEXYL CINNAMAL . LIMONENE.


 MAY CONTAIN/PEUT CONTENIR: CI 77891/TITANIUM DIOXIDE . MICA . CI 77491/CI 77492/ CI 77499/ IRON OXIDES. M2060A

Other

The perfect match between make-up and skin care. A creamy rich foundation that combines exceptional skin firming and age-fighting ingredients for a visibly younger-looking complexion. Delivers a smooth, more radiant, even complexion.


Satin finish - Medium coverage - All skin types. Oil-free. Non-comedogenic. Dermatologist tested.

* Please review the disclaimer below.