Tinted Moisturizer Spf 46 Universal Tint Cream
NDC Package 83286-009-01

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

Package Information

Tinted Moisturizer Spf 46 Universal Tint (zinc oxide, octinoxate) cream is • Apply to face and neck, avoiding the eye area. This formulation utilizes a cream delivery system. Marketed by Drmtlgy, Llc, this product is identified by NDC 83286-009 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
83286-009-01
Package Description
50 mL in 1 BOTTLE
Product Code
83286-009
11-Digit Billing Format
83286000901

Clinical Specifications

Proprietary Name
Tinted Moisturizer Spf 46 Universal Tint
Non-Proprietary Name
Zinc Oxide, Octinoxate
Substance Name
Octinoxate; 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.
Active Ingredient(s)
Pharmacologic Class
Usage Information
• Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours.

Regulatory & Marketing

Labeler Name
Drmtlgy, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-08-2025
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 83286-009-01 identifies a specific commercial package of 50 ml in 1 bottle of Tinted Moisturizer Spf 46 Universal Tint, a human over the counter drug labeled by Drmtlgy, Llc. This cream is formulated for topical use and contains octinoxate; 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 Drmtlgy, Llc on April 08, 2025. The current certification is valid through December 31, 2026.

How is this Drmtlgy, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83286000901. 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)
83286-009-01
11-Digit CMS (5-4-2)
83286-0009-01

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