Cotz Silky Foam - Tinted Aerosol, Foam
NDC Package 58892-430-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cotz Silky Foam - Tinted (titanium dioxide, zinc oxide) aerosols is shake well before using. This formulation utilizes a aerosol, foam delivery system. Marketed by Fallien Cosmeceuticals, Ltd, this product is identified by NDC 58892-430 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
58892-430-01
Package Description
1 CAN in 1 CARTON / 100 g in 1 CAN
Product Code
58892-430
11-Digit Billing Format
58892043001

Clinical Specifications

Proprietary Name
Cotz Silky Foam - Tinted
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; Zinc Oxide
Dosage Form
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
Shake well before using. Push nozzle up to release. Apply liberally 15 minutes before sun exposure. Reapply:After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor Sun 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 sunglasses

Regulatory & Marketing

Labeler Name
Fallien Cosmeceuticals, Ltd
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-29-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 58892-430-01 identifies a specific commercial package of 1 can in 1 carton / 100 g in 1 can of Cotz Silky Foam - Tinted, a human over the counter drug labeled by Fallien Cosmeceuticals, Ltd. This aerosol, foam is formulated for topical use and contains titanium dioxide; zinc oxide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fallien Cosmeceuticals, Ltd on November 29, 2016. The current certification is valid through December 31, 2026.

How is this Fallien Cosmeceuticals, Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58892043001. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
58892-430-01
11-Digit CMS (5-4-2)
58892-0430-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.