One Percent Sunscreen Cream
NDC Package 85176-001-01

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

Package Information

One Percent Sunscreen cream is 1. This formulation utilizes a cream delivery system. Marketed by Beijing Keyan Biotechnology Co., Ltd., this product is identified by NDC 85176-001 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
85176-001-01
Package Description
60 mL in 1 BOTTLE
Product Code
85176-001
11-Digit Billing Format
85176000101

Clinical Specifications

Proprietary Name
One Percent Sunscreen
Non-Proprietary Name
One Percent Sunscreen
Substance Name
Aluminum Hydroxide; Ethylhexyl Methoxycinnamate; Ethylhexyl Salicylate; Phenylbenzimidazole Sulfonic Acid; Titanium Dioxide; Zinc Oxide
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
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
Usage Information
1. Clean the face 2. Moisturizing and hydrating 3. Apply sunscreen

Regulatory & Marketing

Labeler Name
Beijing Keyan Biotechnology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-05-2025
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 85176-001-01 identifies a specific commercial package of 60 ml in 1 bottle of One Percent Sunscreen, a human over the counter drug labeled by Beijing Keyan Biotechnology Co., Ltd.. This cream is formulated for transdermal use and contains aluminum hydroxide; ethylhexyl methoxycinnamate; ethylhexyl salicylate; phenylbenzimidazole sulfonic acid; titanium dioxide; 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 Beijing Keyan Biotechnology Co., Ltd. on February 05, 2025. The current certification is valid through December 31, 2026.

How is this Beijing Keyan Biotechnology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85176000101. 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)
85176-001-01
11-Digit CMS (5-4-2)
85176-0001-01

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