NDC 52554-1200 Cell Fusion C Laser Sunscreen

Zinc Oxide, Homosalate, Octisalate, Titanium Dioxide

NDC Product Code 52554-1200

NDC 52554-1200-1

Package Description: 10 mL in 1 CARTON

NDC 52554-1200-2

Package Description: 50 mL in 1 CARTON

NDC Product Information

Cell Fusion C Laser Sunscreen with NDC 52554-1200 is a a human over the counter drug product labeled by Cms Lab Inc.. The generic name of Cell Fusion C Laser Sunscreen is zinc oxide, homosalate, octisalate, titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cms Lab 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.

Cell Fusion C Laser Sunscreen 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.

  • ZINC OXIDE 12.7 g/100mL
  • HOMOSALATE 7.5 g/100mL
  • OCTISALATE 4.5 g/100mL
  • TITANIUM DIOXIDE 2.2 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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • IDEBENONE (UNII: HB6PN45W4J)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • CERAMIDE NP (UNII: 4370DF050B)
  • SUCROSE STEARATE (UNII: 274KW0O50M)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • CHOLESTERYL MACADAMIATE (UNII: DFP79OD7KP)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)

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: Cms Lab Inc.
Labeler Code: 52554
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: 05-01-2020 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.

Cell Fusion C Laser Sunscreen Product Label Images

Cell Fusion C Laser Sunscreen 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

Active ingredients:ZINC OXIDE 12.70%HOMOSALATE 7.50%ETHYLHEXYL SALICYLATE 4.50%TITANIUM DIOXIDE 2.20%

Purpose

Sunscreen

Uses

Uses■ helps prevent sunburn■ if 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

WarningsFor external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if rash occursKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DirectionsFor sunscreen use:■ apply liberally 15 minutes before sun exposure■ reapply at least every 2 hours■ use a water resistant sunscreen if swimming or sweating■ Sun Protection Measures. Spending time in the sun increases you 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 10a.m.-2p.m.■ wear long-sleeved shirts, pants, hats, and sunglasses■ children under 6 months of age : Ask a doctor

Inactive Ingredients

Inactive ingredientsWater, Cyclopentasiloxane, Dipropylene Glycol, Disiloxane, Lauryl Peg-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Butyloctyl Salicylate, Silica, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, 1,2-Hexanediol, Triethoxycaprylylsilane, Stearic Acid, Aluminum Hydroxide, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Lavandula Angustifolia (Lavender) Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Sodium Citrate, Hydroxydecyl Ubiquinone,Hydrolyzed Collagen, Tocopherol, Hydrogenated Lecithin, Ceramide Np, Sucrose Stearate, Cholesterol, Cholesteryl Macadamiate, Palmitic Acid,Biosaccharide Gum-4, Saccharide Isomerate, Hydrolyzed Lupine Protein

Other Information

Other Informationprotect the product in this container from excessive heat and direct sun

Questions

Questions?+82 080-447-1820;Outside US, dial collect 212-804-7608www.cellfusionc.co.krDist. by Dkcos20 W 33rd St New York, NY 10001www.dkcos.comCMS LAB Inc.Made in Koreawww.cellfusionc.co.kr

* Please review the disclaimer below.