Clarity Rx Physical Skin Defense Lotion
NDC Package 51326-035-01

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

Package Information

Clarity Rx Physical Skin Defense (zinc oxide and titanium dioxide) lotions is apply liberally to face and neck and spread evenly 15 minutes before sun exposureRe-apply after swimming, excessive perspiring, or anytime after towel dryingUse a water resistant sunscreen if swimming or sweatingUse on children under 6 months of age: consult a doctor. This formulation utilizes a lotion delivery system. Marketed by Topiderm, Inc., this product is identified by NDC 51326-035 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
51326-035-01
Package Description
99 g in 1 BOTTLE
Product Code
51326-035
11-Digit Billing Format
51326003501

Clinical Specifications

Proprietary Name
Clarity Rx Physical Skin Defense Spf 50
Non-Proprietary Name
Zinc Oxide And 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 to face and neck and spread evenly 15 minutes before sun exposureRe-apply after swimming, excessive perspiring, or anytime after towel dryingUse a water resistant sunscreen if swimming or sweatingUse on children under 6 months of age: consult a doctor.

Regulatory & Marketing

Labeler Name
Topiderm, Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 51326-035-01 identifies a specific commercial package of 99 g in 1 bottle of Clarity Rx Physical Skin Defense Spf 50, a human over the counter drug labeled by Topiderm, 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 Topiderm, Inc. on January 01, 2022. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51326003501. 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)
51326-035-01
11-Digit CMS (5-4-2)
51326-0035-01

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