Mackenzies Ocean Safe Sunscreen Cream
NDC Package 80325-030-03

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

Package Information

Mackenzies Ocean Safe Sunscreen (titanium dioxide) cream is ■ Apply liberally 15 minutes before sun exposure. This formulation utilizes a cream delivery system. Marketed by Naturally Uncommon, Llc, this product is identified by NDC 80325-030 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
80325-030-03
Package Description
88 mL in 1 TUBE
Product Code
80325-030
11-Digit Billing Format
80325003003

Clinical Specifications

Proprietary Name
Mackenzies Ocean Safe Sunscreen
Non-Proprietary Name
Titanium Dioxide
Substance Name
Titanium Dioxide
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)
TITANIUM DIOXIDE 8.8 g/100mL
Usage Information
■ Apply liberally 15 minutes before sun exposure. ■ Reapply after 80 minutes of swimming or sweating or immediately after towel drying and at least every 2 hours. ■ For children under 6 months of age; ask a doctor.

Regulatory & Marketing

Labeler Name
Naturally Uncommon, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2022
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 80325-030-03 identifies a specific commercial package of 88 ml in 1 tube of Mackenzies Ocean Safe Sunscreen, a human over the counter drug labeled by Naturally Uncommon, Llc. This cream is formulated for topical use and contains titanium dioxide 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 Naturally Uncommon, Llc on July 01, 2022. The current certification is valid through December 31, 2026.

How is this Naturally Uncommon, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80325003003. 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)
80325-030-03
11-Digit CMS (5-4-2)
80325-0030-03

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