Ouhoe Water-permeable Sunscreen Spray
NDC Package 85163-019-01

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

Package Information

Ouhoe Water-permeable Sunscreen (titanium dioxide) sprays is 1. This formulation utilizes a spray delivery system. Marketed by Shantou Ouhoe Technology Co., Ltd., this product is identified by NDC 85163-019 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
85163-019-01
Package Description
100 mg in 1 BOTTLE, SPRAY
Product Code
85163-019
11-Digit Billing Format
85163001901

Clinical Specifications

Proprietary Name
Ouhoe Water-permeable Sunscreen
Non-Proprietary Name
Titanium Dioxide
Substance Name
Artemisia Argyi Leaf
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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)
ARTEMISIA ARGYI LEAF .01 mg/100mg
Usage Information
1. Clean and dry skin2. Open the cover, place it about 15cm away from the skin, and press the pump head towards the skin for use.3. Be careful to avoid your eyes. If it accidentally enters your eyes, please rinse with clean water.

Regulatory & Marketing

Labeler Name
Shantou Ouhoe Technology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-27-2025
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 85163-019-01 identifies a specific commercial package of 100 mg in 1 bottle, spray of Ouhoe Water-permeable Sunscreen, a human over the counter drug labeled by Shantou Ouhoe Technology Co., Ltd.. This spray is formulated for topical use and contains artemisia argyi leaf 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 Shantou Ouhoe Technology Co., Ltd. on December 27, 2025. The current certification is valid through December 31, 2026.

How is this Shantou Ouhoe Technology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85163001901. 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)
85163-019-01
11-Digit CMS (5-4-2)
85163-0019-01

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