Jungsaemmool Essential Skin Nuder Cushion Medium Deep Cream
NDC Package 71261-034-05

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

Package Information

Jungsaemmool Essential Skin Nuder Cushion Medium Deep (titanium dioxide, octinoxate, octisalate) cream is helps prevent sunburn If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun. This formulation utilizes a cream delivery system. Marketed by Jungsaemmool Beauty Co., Ltd., this product is identified by NDC 71261-034 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
71261-034-05
Package Description
1 POUCH in 1 CARTON / 14 g in 1 POUCH (71261-034-04)
Product Code
71261-034
11-Digit Billing Format
71261003405

Clinical Specifications

Proprietary Name
Jungsaemmool Essential Skin Nuder Cushion Medium Deep
Non-Proprietary Name
Titanium Dioxide, Octinoxate, Octisalate
Substance Name
Octinoxate; Octisalate; Titanium Dioxide
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 sunburn If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

Regulatory & Marketing

Labeler Name
Jungsaemmool Beauty Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-29-2024
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71261-034). Click a package code to view its specific billing and regulatory data.

71261-034-02
2 CONTAINER in 1 CARTON / 14 g in 1 CONTAINER (71261-034-01)
71261-034-03
1 CONTAINER in 1 CARTON / 14 g in 1 CONTAINER (71261-034-01)

* 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 71261-034-05 identifies a specific commercial package of 1 pouch in 1 carton / 14 g in 1 pouch (71261-034-04) of Jungsaemmool Essential Skin Nuder Cushion Medium Deep, a human over the counter drug labeled by Jungsaemmool Beauty Co., Ltd.. This cream is formulated for topical use and contains octinoxate; octisalate; titanium dioxide 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 Jungsaemmool Beauty Co., Ltd. on July 29, 2024. The current certification is valid through December 31, 2027.

How is this Jungsaemmool Beauty Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71261003405. 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)
71261-034-05
11-Digit CMS (5-4-2)
71261-0034-05

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