Ciele Filter And Protect Powder
NDC Package 83103-1910-2

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

Package Information

Ciele Filter And Protect (titanium dioxide, zinc oxide) powders is a human otc drug administered via topical route. This formulation utilizes a powder delivery system. Marketed by Ciele, this product is identified by NDC 83103-1910 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
83103-1910-2
Package Description
1 JAR in 1 CARTON / 10 g in 1 JAR (83103-1910-1)
Product Code
83103-1910
11-Digit Billing Format
83103191002

Clinical Specifications

Proprietary Name
Ciele Filter And Protect
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; Zinc Oxide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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)

Regulatory & Marketing

Labeler Name
Ciele
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-25-2023
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 83103-1910-2 identifies a specific commercial package of 1 jar in 1 carton / 10 g in 1 jar (83103-1910-1) of Ciele Filter And Protect, a human over the counter drug labeled by Ciele. This powder 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 Ciele on July 25, 2023. The current certification is valid through December 31, 2026.

How is this Ciele product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83103191002. 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 (5-4-1)
83103-1910-2
11-Digit CMS (5-4-2)
83103-1910-02

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