NDC 10345-914 Erborian Cc Dull Correct Spf25

Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide

NDC Product Code 10345-914

NDC Code: 10345-914

Proprietary Name: Erborian Cc Dull Correct Spf25 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, Octisalate, Titanium Dioxide, Zinc Oxide 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

  • 10345 - Laboratoires M&l
    • 10345-914 - Erborian Cc Dull Correct Spf25

NDC 10345-914-15

Package Description: 1 TUBE in 1 BOX > 15 mL in 1 TUBE

NDC 10345-914-45

Package Description: 1 TUBE in 1 BOX > 45 mL in 1 TUBE

NDC Product Information

Erborian Cc Dull Correct Spf25 with NDC 10345-914 is a a human over the counter drug product labeled by Laboratoires M&l. The generic name of Erborian Cc Dull Correct Spf25 is octinoxate, octisalate, titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Laboratoires M&l

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.

Erborian Cc Dull Correct Spf25 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 60 mg/mL
  • OCTISALATE 20 mg/mL
  • TITANIUM DIOXIDE 47 mg/mL
  • ZINC OXIDE 38.4 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 (UNII: NMQ347994Z)
  • MICA (UNII: V8A1AW0880)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • ULTRAMARINE BLUE (UNII: I39WR998BI)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • TALC (UNII: 7SEV7J4R1U)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • STANNIC OXIDE (UNII: KM7N50LOS6)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • GERANIOL (UNII: L837108USY)
  • EUGENOL (UNII: 3T8H1794QW)
  • 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: Laboratoires M&l
Labeler Code: 10345
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: 05-27-2019 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: 12-31-2020 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.

Erborian Cc Dull Correct Spf25 Product Label Images

Erborian Cc Dull Correct Spf25 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

Ethylhexyl methoxycinnamate / Octinoxate 6.00%Ethylhexyl salicylate / Octisalate 2.00%Titanium dioxide 4.70%Zinc oxide 3.84%

Purpose

Sunscreen

Uses

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

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 exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingSun 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 sunglassesChildren under 6 months of age: Ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

AQUA/WATER - CYCLOMETHICONE - MICA - C12-15 ALKYL BENZOATE - DIPROPYLENE GLYCOL - GLYCERIN - CI 77891/TITANIUM DIOXIDE - PEG-10 DIMETHICONE - METHYL TRIMETHICONE - CI 77007/ULTRAMARINES - DIMETHICONE - BUTYLENE GLYCOL - DISTEARDIMONIUM


HECTORITE - CI 77492/IRON OXIDES - MAGNESIUM SULFATE - CENTELLA ASIATICA EXTRACT - GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT - TALC - VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER - DIMETHICONE/ VINYL DIM E T H I C O N E CROSSPOLYMER - ALUMINUM HYDROXIDE - TRIHYDROXYSTEARIN - METHICONE - PALMITIC ACID - POLYESTER-1 - STEARIC ACID - SILICA DIMETHYL SILYLATE - TOCOPHERYL ACETATE - ETHYLHEXYLGLYCERIN - TIN OXIDE - PHENOXYETHANOL - PARFUM/FRAGRANCE - HEXYL CINNAMAL- ALPHA-ISOMETHYL IONONE - LINALOOL - CITRONELLOL - GERANIOL - EUGENOL - LIMONENE - CI 77491/IRON OXIDES - CI 77499/IRON OXIDES

* Please review the disclaimer below.

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