Sheer Broad Spectrum Spf45 Lotion
NDC Package 67226-2845-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Sheer Broad Spectrum Spf45 (zinc oxide, octocrylene, octinoxate, octisalate) lotions is • Apply daily to face, neck and chest. This formulation utilizes a lotion delivery system. Marketed by Vivier Pharma Inc., this product is identified by NDC 67226-2845 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
67226-2845-2
Package Description
250 mL in 1 TUBE
Product Code
11-Digit Billing Format
67226284502

Clinical Specifications

Proprietary Name
Sheer Broad Spectrum Spf45
Non-Proprietary Name
Zinc Oxide, Octocrylene, Octinoxate, Octisalate
Substance Name
Octinoxate; Octisalate; Octocrylene; Zinc Oxide
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.
Usage Information
• Apply daily to face, neck and chest. • Apply liberally and evenly 15 minutes before sun exposure. • Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing. • For use on children less than 6 months of age, consult a healthcare practitioner. • Use a water resistant sunscreen if swimming or sweating.

Regulatory & Marketing

Labeler Name
Vivier Pharma Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-14-2015
End Marketing Date
09-30-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67226-2845). Click a package code to view its specific billing and regulatory data.

1 TUBE in 1 CARTON / 4 mL in 1 TUBE
1 BOTTLE in 1 CARTON / 90 mL in 1 BOTTLE

* 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 67226-2845-2 identifies a specific commercial package of 250 ml in 1 tube of Sheer Broad Spectrum Spf45, a human over the counter drug labeled by Vivier Pharma Inc.. This lotion is formulated for topical use and contains octinoxate; octisalate; octocrylene; 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 Vivier Pharma Inc. on May 14, 2015.

How is this Vivier Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67226284502. 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 (5-4-1)
67226-2845-2
11-Digit CMS (5-4-2)
67226-2845-02

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