Dermisa Sunscreen Spf 55
NDC Package 68343-003-04

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Dermisa Sunscreen Spf 55 is • apply 15 minutes before sun exposure • reapply • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • Sun Protection Measures. Marketed by Montani Cosmetics Inc, this product is identified by NDC 68343-003 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
68343-003-04
Package Description
118 mL in 1 TUBE
Product Code
68343-003
11-Digit Billing Format
68343000304

Clinical Specifications

Proprietary Name
Dermisa Sunscreen Spf 55 Broad Spectrum
Dosage Form
-
Usage Information
• apply 15 minutes before sun exposure • reapply • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 of 15 or higher and other sun protection measures including: • limit time in sun, especially from 10 a.m.- 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: Ask a Doctor

Regulatory & Marketing

Labeler Name
Montani Cosmetics Inc
FDA Application #
part352
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
09-08-2017
Listing Expiration
12-31-2019
Exclude Flag
I
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 68343-003-04 identifies a specific commercial package of 118 ml in 1 tube of Dermisa Sunscreen Spf 55 Broad Spectrum, labeled by Montani Cosmetics Inc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Montani Cosmetics Inc on September 08, 2017. The current certification is valid through December 31, 2019.

How is this Montani Cosmetics Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68343000304. 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)
68343-003-04
11-Digit CMS (5-4-2)
68343-0003-04

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