Ultra Sunscreen Emulsion
NDC Package 85448-003-01

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

Package Information

Ultra Sunscreen (octinoxate, octisalate, titanium dioxide) emulsions is soothing + Moisturizing. This formulation utilizes a emulsion delivery system. Marketed by Jiangsu Senwo Medical Technology Co., Ltd., this product is identified by NDC 85448-003 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
85448-003-01
Package Description
473 mL in 1 BOTTLE
Product Code
85448-003
11-Digit Billing Format
85448000301

Clinical Specifications

Proprietary Name
Ultra Sunscreen
Non-Proprietary Name
Octinoxate, Octisalate, Titanium Dioxide
Substance Name
Octinoxate; Octisalate; Titanium Dioxide
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
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
Soothing + Moisturizing

Regulatory & Marketing

Labeler Name
Jiangsu Senwo Medical Technology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-07-2026
Listing Expiration
12-31-2027
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 85448-003-01 identifies a specific commercial package of 473 ml in 1 bottle of Ultra Sunscreen, a human over the counter drug labeled by Jiangsu Senwo Medical Technology Co., Ltd.. This emulsion is formulated for topical use and contains octinoxate; octisalate; 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 Jiangsu Senwo Medical Technology Co., Ltd. on April 07, 2026. The current certification is valid through December 31, 2027.

How is this Jiangsu Senwo Medical Technology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85448000301. 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)
85448-003-01
11-Digit CMS (5-4-2)
85448-0003-01

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