NDC 73655-090 Celonia Signature Bio Tone Up Sun Block

Homosalate, Octisalate, Titanium Dioxide, Avobenzone

NDC Product Code 73655-090

NDC CODE: 73655-090

Proprietary Name: Celonia Signature Bio Tone Up Sun Block 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, Octisalate, Titanium Dioxide, Avobenzone 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

  • 73655 - Celino Inc.
    • 73655-090 - Celonia Signature Bio Tone Up Sun Block

NDC 73655-090-02

Package Description: 1 CONTAINER in 1 CARTON > 50 mL in 1 CONTAINER (73655-090-01)

NDC Product Information

Celonia Signature Bio Tone Up Sun Block with NDC 73655-090 is a a human over the counter drug product labeled by Celino Inc.. The generic name of Celonia Signature Bio Tone Up Sun Block is homosalate, octisalate, titanium dioxide, avobenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Celino Inc.

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.

Celonia Signature Bio Tone Up Sun Block 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.

  • HOMOSALATE 5 g/50mL
  • OCTISALATE 2.5 g/50mL
  • TITANIUM DIOXIDE 2.13 g/50mL
  • AVOBENZONE 1.5 g/50mL

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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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.
  • 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: Celino Inc.
Labeler Code: 73655
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: 02-01-2020 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 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.

Celonia Signature Bio Tone Up Sun Block Product Label Images

Celonia Signature Bio Tone Up Sun Block 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

Active ingredients: Homosalate 10.0%, Ethylhexyl Salicylate 5.0%, Titanium Dioxide 4.26%, Butyl Methoxydibenzoylmethane 3.0%

Inactive Ingredient

Inactive ingredients:Water, Butylene Glycol,Cyclopentasiloxane,EthylhexylPalmitate,Glycerin,Neopentyl Glycol, Diheptanoate,Cyclohexasiloxane,Niacinamide,Caprylyl Methicone,Eclipta Prostrata Extract,Melia Azadirachta Leaf Extract,Human Cord Blood Cell Conditioned Media(100ppm),Moringa Oleifera Seed Oil,Hydrolyzed Vegetable Protein,Salvia Officinalis (Sage) Leaf Extract,Pentylene Glycol,Propanediol,Dimethicone,Triceteareth-4 Phosphate,Glyceryl Stearate,PEG-100 Stearate,Glycol Stearate,Silica,PEG-2 Stearate,Potassium Cetyl Phosphate,Sorbitan Sesquioleate,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Caprylyl Glycol,Glyceryl Caprylate,Tromethamine,Ethylhexylglycerin,Adenosine,Squalane,Maltodextrin,Tocopherol,Sodium Chloride,Sodium Bicarbonate,Glucose,Potassium Chloride,Glutamine,Calcium Chloride,Sodium Phosphate,Sodium Pyruvate,Arginine,Cysteine HCl,Cyanocobalamin,Magnesium Sulfate,Thioctic Acid,Glutamic Acid,Lysine,Isoleucine,Leucine,Ascorbic Acid,Asparagine,Glycine,Threonine,Valine,Proline,Phenylalanine,Histidine,Aspartic Acid,Alanine,Serine,Methionine,Ferrous Sulfate,Guanosine,Tryptophan,Inositol,Calcium Pantothenate,Folic Acid,Pyridoxine HCl,Thiamine HCl,Biotin,Riboflavin,Stearyl Alcohol,Cetyl Alcohol,Xanthan Gum,Disodium EDTA,Tin Oxide (CI 77861),Myristyl Alcohol,Lauryl Alcohol,Fragrance(Parfum),Mica (CI 77019)

Purpose

Purpose: Sunscreen

Warnings

Warnings:1. Stop using this product and see a dermatologist, if skin swelling, itching or skin rashes appear after using this product or by exposure to sun light 2. Refrain from applying the product on wounded skin area 3. Cautions during storage and handling a) keep out of reach from infants and children b) store away from direct sunlight 4. Wash out immediately when in contact with eyes

Questions

Questions:080-750-1800 www.celonia.co.kr

Description

Uses:Key ingredients: Human cord blood stem cell conditioned media / Defined cell culture mediaUV protection of SPF50+ / PA++++Natural 0.3 tone up effectDirections: Take desired amount of the product and evenly spread on the skin of sunlight exposure. Re-apply as much as needed upon long exposure to the sunlight for complete protection of your skin after intensive Cell Training

* Please review the disclaimer below.