Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen Lotion
NDC Package 0023-5675-08

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

Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen (titanium dioxide and zinc oxide) lotions is apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Sun Protection Measures Spending time in the sun increases the risk of skin cancer, premature skin aging and other skin damage. This formulation utilizes a lotion delivery system. Marketed by Allergan, Inc., this product is identified by NDC 0023-5675 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
0023-5675-08
Package Description
1 BOTTLE in 1 CARTON / 227 g in 1 BOTTLE
Product Code
0023-5675
11-Digit Billing Format
00023567508

Clinical Specifications

Proprietary Name
Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen
Non-Proprietary Name
Titanium Dioxide And Zinc Oxide
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 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Sun Protection Measures Spending time in the sun increases the risk of skin cancer, premature skin aging and other skin damage. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including limiting time in the sun from 10 a.m.-2 p.m., and wearing protective clothing Children under 6 months: Ask a doctor

Regulatory & Marketing

Labeler Name
Allergan, Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-16-2016
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 (0023-5675). Click a package code to view its specific billing and regulatory data.

0023-5675-13
12 TUBE in 1 CARTON / 3.68 g in 1 TUBE
0023-5675-17
1 TUBE in 1 CARTON / 52.5 g in 1 TUBE
0023-5675-25
6 TUBE in 1 CARTON / 7.1 g in 1 TUBE

* 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 0023-5675-08 identifies a specific commercial package of 1 bottle in 1 carton / 227 g in 1 bottle of Essential Defense Mineral Shield Broad Spectrum Spf 32 Tinted Sunscreen, a human over the counter drug labeled by Allergan, 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 Allergan, Inc. on March 16, 2016. The current certification is valid through December 31, 2026.

How is this Allergan, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00023567508. 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 (4-4-2)
0023-5675-08
11-Digit CMS (5-4-2)
00023-5675-08

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