NDC 58832-0001 Luacell Illuminating White Label Sun Cream

Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane, Octocrylene

NDC Product Code 58832-0001

NDC Code: 58832-0001

Proprietary Name: Luacell Illuminating White Label Sun Cream 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: Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane, Octocrylene 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

  • 58832 - Eyesome. Co.,ltd.
    • 58832-0001 - Luacell Illuminating White Label Sun Cream

NDC 58832-0001-1

Package Description: 3 TUBE in 1 CONTAINER > 25 mL in 1 TUBE

NDC Product Information

Luacell Illuminating White Label Sun Cream with NDC 58832-0001 is a a human over the counter drug product labeled by Eyesome. Co.,ltd.. The generic name of Luacell Illuminating White Label Sun Cream is homosalate, ethylhexyl salicylate, butyl methoxydibenzoylmethane, octocrylene. The product's dosage form is cream and is administered via topical form.

Labeler Name: Eyesome. Co.,ltd.

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.

Luacell Illuminating White Label Sun Cream 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.

  • OCTOCRYLENE 2.5 g/100mL
  • OCTISALATE 4 g/100mL
  • AVOBENZONE 3 g/100mL
  • HOMOSALATE 9 g/100mL

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)
  • DIMETHICONE (UNII: 92RU3N3Y1O)

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: Eyesome. Co.,ltd.
Labeler Code: 58832
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: 08-28-2019 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.

Luacell Illuminating White Label Sun Cream Product Label Images

Luacell Illuminating White Label Sun Cream 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

Otc - Active Ingredient

Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane, Octocrylene

Inactive Ingredient

Water, Dimethicone, Slica, etc

Otc - Purpose

Sunscreen

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Take an appropriate amount, spread it gently according to the skin texture, and tap it softly to absorb it.

Warnings

  • Do not use on broken or irritated skinStorage & Handling
  • 1) Keep out of reach from children
  • 2) Keep out of sunlight
  • 3) Avoid contact with eyes

Dosage & Administration

For external use only

* Please review the disclaimer below.