Skin Defense Matte Tinted Sunscreen Cream
NDC Package 85366-208-50

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

Package Information

Skin Defense Matte Tinted Sunscreen (zinc oxide) cream is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a cream delivery system. Marketed by Gentlehomme Llc, this product is identified by NDC 85366-208 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
85366-208-50
Package Description
50 g in 1 BOTTLE, PUMP
Product Code
85366-208
11-Digit Billing Format
85366020850

Clinical Specifications

Proprietary Name
Skin Defense Matte Tinted Sunscreen
Non-Proprietary Name
Zinc Oxide
Substance Name
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)
ZINC OXIDE 160 mg/g
Usage Information
This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

Regulatory & Marketing

Labeler Name
Gentlehomme Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-28-2024
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 85366-208-50 identifies a specific commercial package of 50 g in 1 bottle, pump of Skin Defense Matte Tinted Sunscreen, a human over the counter drug labeled by Gentlehomme Llc. This cream is formulated for topical use and contains 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 Gentlehomme Llc on February 28, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

How is this Gentlehomme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85366020850. 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)
85366-208-50
11-Digit CMS (5-4-2)
85366-0208-50

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