Round Lab Birch Juice Moisturizing Uvlock Sun Cushion Sponge
NDC Package 84616-004-01

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

Package Information

Round Lab Birch Juice Moisturizing Uvlock Sun Cushion (zinc oxide) sponges is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a sponge delivery system. Marketed by Seorin Company Co., Ltd., this product is identified by NDC 84616-004 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
84616-004-01
Package Description
15 g in 1 CONTAINER
Product Code
84616-004
11-Digit Billing Format
84616000401

Clinical Specifications

Proprietary Name
Round Lab Birch Juice Moisturizing Uvlock Sun Cushion
Non-Proprietary Name
Zinc Oxide
Substance Name
Zinc Oxide
Dosage Form
Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.
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)
ZINC OXIDE 22.28325 g/100g
Usage Information
This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

Regulatory & Marketing

Labeler Name
Seorin Company Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-06-2024
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 84616-004-01 identifies a specific commercial package of 15 g in 1 container of Round Lab Birch Juice Moisturizing Uvlock Sun Cushion, a human over the counter drug labeled by Seorin Company Co., Ltd.. This sponge is formulated for topical use and contains 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 Seorin Company Co., Ltd. on November 06, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

How is this Seorin Company Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84616000401. 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)
84616-004-01
11-Digit CMS (5-4-2)
84616-0004-01

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