Woodsleep Tallow Sunscreen Cream
NDC Package 85053-002-01

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

Package Information

Woodsleep Tallow Sunscreen (titanium dioxide) cream is a medication used as Sunscreen barrier: fully blocks UV rays and protects skin health. This formulation utilizes a cream delivery system. Marketed by Shantou Woodsleep Biotechnology Co., Ltd., this product is identified by NDC 85053-002 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
85053-002-01
Package Description
57 mg in 1 BOX
Product Code
85053-002
11-Digit Billing Format
85053000201

Clinical Specifications

Proprietary Name
Woodsleep Tallow Sunscreen
Non-Proprietary Name
Titanium Dioxide
Substance Name
Tallow
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)
TALLOW .0114 mg/57mg
Usage Information
This product is used as Sunscreen barrier: fully blocks UV rays and protects skin health. Deep moisturizing: prevents dryness and keeps skin moisturized. Sports adaptability: swimming and fitness without makeup removal, more lasting protection. Lightweight and comfortable: silky and fits the skin, no burden to the touch. Suitable for daily commuting, can be used alone or as a primer before makeup. Mild formula reduces irritation, sensitive skin friendly. Improves skin smoothness and soft touch. Light texture, does not clog pores. Suitable for a variety of skin types and skin tones, easy to control. Re-application does not rub mud, convenient and not embarrassing. Balance the water and oil status of the skin to avoid drying. Reduce the loss of protective power caused by the external environment. Natural nude makeup effect, no fake face and no oily shine. Portable packaging design, worry-free re-application anytime, anywhere. Strengthen the skin's ability to resist daily environmental pressure.

Regulatory & Marketing

Labeler Name
Shantou Woodsleep Biotechnology Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-18-2025
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 85053-002-01 identifies a specific commercial package of 57 mg in 1 box of Woodsleep Tallow Sunscreen, a human over the counter drug labeled by Shantou Woodsleep Biotechnology Co., Ltd.. This cream is formulated for topical use and contains tallow 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 Woodsleep Biotechnology Co., Ltd. on April 18, 2025. The current certification is valid through December 31, 2026.

How is this Shantou Woodsleep Biotechnology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85053000201. 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)
85053-002-01
11-Digit CMS (5-4-2)
85053-0002-01

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