Sunscreen Powder
NDC Package 83447-001-01

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

Package Information

Sunscreen Powder powders is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a powder delivery system. Marketed by Guangzhou Fantesy Biotechnology Co.,ltd, this product is identified by NDC 83447-001 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
83447-001-01
Package Description
3.5 g in 1 BOX
Product Code
83447-001
11-Digit Billing Format
83447000101

Clinical Specifications

Proprietary Name
Sunscreen Powder
Non-Proprietary Name
Sunscreen Powder
Substance Name
Zinc Oxide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Administration Route
Cutaneous - Administration to the skin.
Active Ingredient(s)
ZINC OXIDE 25 g/100g
Usage Information
This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

Regulatory & Marketing

Labeler Name
Guangzhou Fantesy Biotechnology Co.,ltd
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-05-2023
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 83447-001-01 identifies a specific commercial package of 3.5 g in 1 box of Sunscreen Powder, a human over the counter drug labeled by Guangzhou Fantesy Biotechnology Co.,ltd. This powder is formulated for cutaneous use and contains 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 Guangzhou Fantesy Biotechnology Co.,ltd on May 05, 2023. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

How is this Guangzhou Fantesy Biotechnology Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83447000101. 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)
83447-001-01
11-Digit CMS (5-4-2)
83447-0001-01

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