Erborian Double Sample Cc Creme Clair And Dore Spf 25 Kit
NDC Package 10345-921-01

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

Package Information

Erborian Double Sample Cc Creme Clair And Dore Spf 25 (octinoxate, octisalate, titanium dioxide, zinc oxide) kits is for sunscreen use:Apply liberally 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingSunProtectionMeasures. This formulation utilizes a kit delivery system. Marketed by Laboratoires M&l, this product is identified by NDC 10345-921 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
10345-921-01
Package Description
1 KIT in 1 KIT * 1.5 mL in 1 PACKET (10345-911-01) * 1.5 mL in 1 PACKET (10345-910-01)
Product Code
10345-921
11-Digit Billing Format
10345092101

Clinical Specifications

Proprietary Name
Erborian Double Sample Cc Creme Clair And Dore Spf 25
Non-Proprietary Name
Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide
Dosage Form
Kit - A packaged collection of related material.
Usage Information
For sunscreen use:Apply liberally 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingSunProtectionMeasures. Spending time in the sun increases your riskofskincancerandearlyskinaging. Todecreasethisrisk, 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-sleeved shirts, pants, hats and sunglassesChildren under 6 months of age: Ask a doctor

Regulatory & Marketing

Labeler Name
Laboratoires M&l
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-03-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 10345-921-01 identifies a specific commercial package of 1 kit in 1 kit * 1.5 ml in 1 packet (10345-911-01) * 1.5 ml in 1 packet (10345-910-01) of Erborian Double Sample Cc Creme Clair And Dore Spf 25, a human over the counter drug labeled by Laboratoires M&l. This kit is formulated for use and contains 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 Laboratoires M&l on December 03, 2017. The current certification is valid through December 31, 2026.

How is this Laboratoires M&l product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10345092101. 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)
10345-921-01
11-Digit CMS (5-4-2)
10345-0921-01

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