Advanced Anti-wrinkle Therapy Cream
NDC Package 50066-021-01

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

Package Information

Advanced Anti-wrinkle Therapy (avobenxone 3%, octinoxate 7.5%, octisalate 5%, octocrylene 2.7%, oxybenzone 4%) cream is for sunscreen use: • apply generously and evenly 15 minutes before sun exposure. This formulation utilizes a cream delivery system. Marketed by Genomma Lab, this product is identified by NDC 50066-021 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
50066-021-01
Package Description
1 TUBE in 1 CARTON / 42 g in 1 TUBE
Product Code
50066-021
11-Digit Billing Format
50066002101

Clinical Specifications

Proprietary Name
Advanced Anti-wrinkle Therapy Cicatricure
Non-Proprietary Name
Avobenxone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 2.7%, Oxybenzone 4%
Substance Name
Avobenzone; Octinoxate; Octisalate; Octocrylene; Oxybenzone
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)
Usage Information
For sunscreen use: • apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF factor of 15 or higher and other skin protection measures including: • limit time in the sun, especially from 10am to 2pm • wear long-sleeved shirts, pants, hats and sunglasses • children under 6 months of age: ask a doctor

Regulatory & Marketing

Labeler Name
Genomma Lab
Product Type
Human Otc Drug
FDA Application #
part352
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
01-21-2019
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 50066-021-01 identifies a specific commercial package of 1 tube in 1 carton / 42 g in 1 tube of Advanced Anti-wrinkle Therapy Cicatricure, a human over the counter drug labeled by Genomma Lab. This cream is formulated for topical use and contains avobenzone; octinoxate; octisalate; octocrylene; oxybenzone 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 Genomma Lab on January 21, 2019. The current certification is valid through December 31, 2026.

How is this Genomma Lab product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50066002101. 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)
50066-021-01
11-Digit CMS (5-4-2)
50066-0021-01

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