Sheltered Broad Spectrum Spf 55 Sunscreen
NDC Package 68634-050-01

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.

Sheltered Broad Spectrum Spf 55 Sunscreen is apply liberally 15 minutes prior to sun exposure to face, neck and areas exposed to the sun. Marketed by Amcol Health & Beauty Solutions, Inc. Dba, this product is identified by NDC 68634-050 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
68634-050-01
Package Description
1 BOTTLE in 1 CARTON / 50 mL in 1 BOTTLE
Product Code
68634-050
11-Digit Billing Format
68634005001

Clinical Specifications

Proprietary Name
Sheltered Broad Spectrum Spf 55 Sunscreen
Dosage Form
-
Usage Information
Apply liberally 15 minutes prior to sun exposure to face, neck and areas exposed to the sun. Re-apply after swimming, sweating or after 2 hours.

Regulatory & Marketing

Labeler Name
Amcol Health & Beauty Solutions, Inc. Dba
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
09-01-2015
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 68634-050-01 identifies a specific commercial package of 1 bottle in 1 carton / 50 ml in 1 bottle of Sheltered Broad Spectrum Spf 55 Sunscreen, labeled by Amcol Health & Beauty Solutions, Inc. Dba. 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 Amcol Health & Beauty Solutions, Inc. Dba on September 01, 2015. The current certification is valid through December 31, 2019.

How is this Amcol Health & Beauty Solutions, Inc. Dba product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68634005001. 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)
68634-050-01
11-Digit CMS (5-4-2)
68634-0050-01

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