NDC 67692-821 Lumene Cc Color Correcting Sunscreen Broad Spectrum Spf 20 Light

Octinoxate, Titanium Dioxide

NDC Product Code 67692-821

NDC CODE: 67692-821

Proprietary Name: Lumene Cc Color Correcting Sunscreen Broad Spectrum Spf 20 Light 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

  • 67692 - Lumene Oy
    • 67692-821 - Lumene Cc Color Correcting Sunscreen Broad Spectrum Spf 20 Light

NDC 67692-821-00

Package Description: 1 TUBE in 1 BOX > 30 mL in 1 TUBE

NDC Product Information

Lumene Cc Color Correcting Sunscreen Broad Spectrum Spf 20 Light with NDC 67692-821 is a a human over the counter drug product labeled by Lumene Oy. The generic name of Lumene Cc Color Correcting Sunscreen Broad Spectrum Spf 20 Light is octinoxate, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Lumene Oy

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.

Lumene Cc Color Correcting Sunscreen Broad Spectrum Spf 20 Light 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 40 mg/mL
  • TITANIUM DIOXIDE 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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • ISODODECANE (UNII: A8289P68Y2)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • MICA (UNII: V8A1AW0880)
  • NYLON-12 (UNII: 446U8J075B)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • LINGONBERRY SEED OIL (UNII: 44P1VFO6KM)
  • RUBUS CHAMAEMORUS WHOLE (UNII: O90MY5Z91V)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • ROSEMARY (UNII: IJ67X351P9)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)

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: Lumene Oy
Labeler Code: 67692
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: 03-29-2017 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.

Lumene Cc Color Correcting Sunscreen Broad Spectrum Spf 20 Light Product Label Images

Lumene Cc Color Correcting Sunscreen Broad Spectrum Spf 20 Light 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 4.0%Titanium dioxide 0.8%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

For external use only.

Do Not Ues

On damaged or broken skin.

Stop Use And Ask A Doctor If

Rash occurs.

When Using This Product,

Keep out of eyes. Rinse with water to remove.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poson Control Center right away.

Directions

  • 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

Inacitve Ingredients

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, ISODODECANE, DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, MAGNESIUM SULFATE, CETYL PEG/PPF-10/1 DIMETHICONE, HEXYL LAURATE, MICA, NYLON-12, PROPYLENE GLYCOL, LINGONBERRY (VACCINIUM VITIS-IDAEA) SEED OIL, CLOUDBERRY (RUBUS CHAMAEMORUS) SEED EXTRACT, CETEARYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, PERFLUOROOCTYL TRIETHOXYSILANE, ALUMINUM HYDROXIDE, PROPANEDIOL, PROPYLENE CARBONATE, METHICONE, ETHYLHEXYLGLYCERIN, GLYCERIN, ALUMINA, TRIETHOXYCAPRYLYLSILANE, SUNFLOWER (HELIANTHUS ANNUUS) SEED OIL, ROSEMARY (ROSMARINUS OFFICINALIS) LEAF EXTRACT, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES

Other Information

Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.