Sei Bella Tinted Bb Moisturizing Creme Lotion
NDC Package 54473-310-01

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

Package Information

Sei Bella Tinted Bb Moisturizing Creme (titanium dioxide 5% and zinc oxide 5%) lotions is apply after cleanser, toner, and foundation primer. This formulation utilizes a lotion delivery system. Marketed by Melaleuca Inc., this product is identified by NDC 54473-310 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
54473-310-01
Package Description
1 BOTTLE, DISPENSING in 1 BOX / 30 mL in 1 BOTTLE, DISPENSING (54473-310-30)
Product Code
54473-310
11-Digit Billing Format
54473031001

Clinical Specifications

Proprietary Name
Sei Bella Tinted Bb Moisturizing Creme Sheer To Light 140 N
Non-Proprietary Name
Titanium Dioxide 5% And Zinc Oxide 5%
Substance Name
Titanium Dioxide; Zinc Oxide
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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
Apply after cleanser, toner, and foundation primer. Blend outward with Sei Bella foundation brush or fingers.apply liberally 15 minutes before sun exposureuse a water-resistant sunscreen if swimming or sweatingreapply at least every 2 hourschildren under 6 months: ask a doctorSun 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 10 a.m.-2 p.m.wear long-sleeve shirts, pants, hats, and sunglasses

Regulatory & Marketing

Labeler Name
Melaleuca Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2018
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 54473-310-01 identifies a specific commercial package of 1 bottle, dispensing in 1 box / 30 ml in 1 bottle, dispensing (54473-310-30) of Sei Bella Tinted Bb Moisturizing Creme Sheer To Light 140 N, a human over the counter drug labeled by Melaleuca Inc.. This lotion 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 Melaleuca Inc. on May 01, 2018. 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: 54473031001. 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)
54473-310-01
11-Digit CMS (5-4-2)
54473-0310-01

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