La Defense Broad Spectrum Spf 30 Mineral Sunscreen Lotion
NDC Package 63127-101-01

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 Defense Broad Spectrum Spf 30 Mineral Sunscreen (zinc oxide, titanium dioxide) lotions is apply liberally/generously (and evenly) 15 minutes before sun exposure; Reapply at least every 2 hours or after swimming, towel drying, perspiring heavily and washing; and for use on children less than 6 months of age, consult a health care practitioner.Sun Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging. This formulation utilizes a lotion delivery system. Marketed by Luzern Laboratories, Inc, this product is identified by NDC 63127-101 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
63127-101-01
Package Description
1 TUBE in 1 CARTON / 60 mL in 1 TUBE
Product Code
63127-101
11-Digit Billing Format
63127010101

Clinical Specifications

Proprietary Name
La Defense Broad Spectrum Spf 30 Mineral Sunscreen
Non-Proprietary Name
Zinc Oxide, Titanium Dioxide
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 liberally/generously (and evenly) 15 minutes before sun exposure; Reapply at least every 2 hours or after swimming, towel drying, perspiring heavily and washing; and for use on children less than 6 months of age, consult a health care practitioner.Sun 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 measures including:•Limit time in the sun, especially from 10am – 2pm.•Wear Long-sleeved shirts, pants, hats and sunglasses.•Reapply after 40 minutes of swimming or sweating.•Reapply immediately after towel drying.

Regulatory & Marketing

Labeler Name
Luzern Laboratories, Inc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-10-2021
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 (63127-101). Click a package code to view its specific billing and regulatory data.

63127-101-02
3 mL in 1 TUBE
63127-101-03
240 mL in 1 BOTTLE

* 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 63127-101-01 identifies a specific commercial package of 1 tube in 1 carton / 60 ml in 1 tube of La Defense Broad Spectrum Spf 30 Mineral Sunscreen, a human over the counter drug labeled by Luzern Laboratories, 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 Luzern Laboratories, Inc on May 10, 2021. The current certification is valid through December 31, 2026.

How is this Luzern Laboratories, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63127010101. 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)
63127-101-01
11-Digit CMS (5-4-2)
63127-0101-01

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