Proper Protection Plus Primer Nt Cream
NDC Package 85358-202-15

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

Proper Protection Plus Primer Nt (titanium dioxide, zinc oxide) cream is a human otc drug administered via topical route. This formulation utilizes a cream delivery system. Marketed by Skin & Proper Llc, this product is identified by NDC 85358-202 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
85358-202-15
Package Description
1.5 g in 1 PACKET
Product Code
85358-202
11-Digit Billing Format
85358020215

Clinical Specifications

Proprietary Name
Proper Protection Plus Primer Nt
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; Zinc Oxide
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.
  • 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)

Regulatory & Marketing

Labeler Name
Skin & Proper Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (85358-202). Click a package code to view its specific billing and regulatory data.

85358-202-50
53 g in 1 BOTTLE, PUMP

* 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 85358-202-15 identifies a specific commercial package of 1.5 g in 1 packet of Proper Protection Plus Primer Nt, a human over the counter drug labeled by Skin & Proper Llc. This cream 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 Skin & Proper Llc on July 15, 2024. The current certification is valid through December 31, 2026.

How is this Skin & Proper Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85358020215. 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)
85358-202-15
11-Digit CMS (5-4-2)
85358-0202-15

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