Sei Bella Daily Uv Defense Cream
NDC Package 54473-403-01

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

Package Information

Sei Bella Daily Uv Defense (sunscreen) cream is helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer caused by the sun. This formulation utilizes a cream delivery system. Marketed by Melaleuca Inc., this product is identified by NDC 54473-403 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
54473-403-01
Package Description
74 mL in 1 TUBE
Product Code
54473-403
11-Digit Billing Format
54473040301

Clinical Specifications

Proprietary Name
Sei Bella Daily Uv Defense Broad-spectrum Spf 25 Sunscreen
Non-Proprietary Name
Sunscreen
Substance Name
Homosalate; Octisalate; Octocrylene; Titanium Dioxide; Zinc Oxide
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.
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
Helps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer caused by the sun

Regulatory & Marketing

Labeler Name
Melaleuca Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2024
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 54473-403-01 identifies a specific commercial package of 74 ml in 1 tube of Sei Bella Daily Uv Defense Broad-spectrum Spf 25 Sunscreen, a human over the counter drug labeled by Melaleuca Inc.. This cream is formulated for topical use and contains homosalate; octisalate; octocrylene; 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 Melaleuca Inc. on May 01, 2024. The current certification is valid through December 31, 2026.

How is this Melaleuca Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54473040301. 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)
54473-403-01
11-Digit CMS (5-4-2)
54473-0403-01

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