NDC 73655-080 Celonia Signature Bio Cushion Pact Pink Ivory

Titanium Dioxide

NDC Product Code 73655-080

NDC 73655-080-02

Package Description: 1 CONTAINER in 1 CARTON > 14 g in 1 CONTAINER (73655-080-01)

NDC Product Information

Celonia Signature Bio Cushion Pact Pink Ivory with NDC 73655-080 is a a human over the counter drug product labeled by Celino Inc.. The generic name of Celonia Signature Bio Cushion Pact Pink Ivory is titanium dioxide. The product's dosage form is powder and is administered via topical form.

Labeler Name: Celino Inc.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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 Cushion Pact Pink Ivory 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.

  • TITANIUM DIOXIDE 2.1 g/14g

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)

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 Cushion Pact Pink Ivory Product Label Images

Celonia Signature Bio Cushion Pact Pink Ivory 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: Titanium Dioxide 15.06%

Inactive Ingredient

Inactive ingredients:Water,Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone , Trimethylsiloxysilicate, Butylene Glycol, Isododecane, Dimethicone, Niacinamide , Triethyl Citrate, 1,2-Hexanediol, PEG/PPG-18/18 Dimethicone, Polypropylsilsesquioxane, PEG-9 Polydimethylsiloxyethyl Dimethicone, Magnesium Sulfate, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Human Cord Blood Cell Conditioned Media, Raspberry Seed Oil/Tocopheryl Succinate Aminopropanediol Esters, Polyglyceryl-3 Diisostearate, Polymethylsilsesquioxane, Tocopheryl Acetate, Aluminum Hydroxide, Stearic Acid, Alumina, Triethoxycaprylylsilane, Ethylhexylglycerin, Glyceryl Caprylate, Adenosine, PEG-10 Dimethicone, Disteardimonium Hectorite, Squalane, Sodium Chloride, Sodium Bicarbonate, Glucose, Potassium Chloride, Glutamine, Calcium Chloride, Sodium Phosphate, Sodium Pyruvate, Arginine, Cysteine HCl, 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, Cyanocobalamin, Calcium Pantothenate, Folic Acid, Pyridoxine HCl, Thiamine HCl, Biotin, Riboflavin, Disodium EDTA, Fragrance(Parfum), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

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 SPF45 / PA++The film-former technology gives long-lasting and constant facial coverageTwo choices in color by your skin tone (pink ivory and ivory)Directions: Put puff on the base for desired amount and pat the puff softly and evenly over your face

* Please review the disclaimer below.