La Mer The Radiant Skintint Broad Spectrum Spf 30 Cream
NDC Package 65966-021-01

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

La Mer The Radiant Skintint Broad Spectrum Spf 30 (octinoxate, octisalate, and titanium dioxide) cream is for sunscreen use:apply liberally 15 minutes before sun exposurereapply at least every two hoursuse a water resistant sunscreen if swimming or sweatingSun Protection Measures. This formulation utilizes a cream delivery system. Marketed by Max Huber Research Lab Inc, this product is identified by NDC 65966-021 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
65966-021-01
Package Description
1 TUBE in 1 CARTON / 40 mL in 1 TUBE
Product Code
65966-021
11-Digit Billing Format
65966002101

Clinical Specifications

Proprietary Name
La Mer The Radiant Skintint Broad Spectrum Spf 30
Non-Proprietary Name
Octinoxate, Octisalate, And Titanium Dioxide
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
For sunscreen use:apply liberally 15 minutes before sun exposurereapply at least every two hoursuse a water resistant sunscreen if swimming or sweatingSun Protection Measures. Spending time in the sun increases your 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-sleeved shirts, pants, hats and sunglasseschildren under 6 months of age: ask a doctor

Regulatory & Marketing

Labeler Name
Max Huber Research Lab Inc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-26-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65966-021). Click a package code to view its specific billing and regulatory data.

65966-021-02
3 mL in 1 PACKET

* 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 65966-021-01 identifies a specific commercial package of 1 tube in 1 carton / 40 ml in 1 tube of La Mer The Radiant Skintint Broad Spectrum Spf 30, a human over the counter drug labeled by Max Huber Research Lab Inc. 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 Max Huber Research Lab Inc on February 26, 2020. The current certification is valid through December 31, 2026.

How is this Max Huber Research Lab Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65966002101. 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)
65966-021-01
11-Digit CMS (5-4-2)
65966-0021-01

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