Sky And Sol Spf25 Lip Balm Paste
NDC Package 83447-009-01

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

Package Information

Sky And Sol Spf25 Lip Balm pastes is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a paste delivery system. Marketed by Guangzhou Fantesy Biotechnology Co.,ltd, this product is identified by NDC 83447-009 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
83447-009-01
Package Description
9 g in 1 BOX
Product Code
83447-009
11-Digit Billing Format
83447000901

Clinical Specifications

Proprietary Name
Sky And Sol Spf25 Lip Balm
Non-Proprietary Name
Sky And Sol Spf25 Lip Balm
Substance Name
Zinc Oxide
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty 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)
ZINC OXIDE 15 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 #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-09-2024
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 83447-009-01 identifies a specific commercial package of 9 g in 1 box of Sky And Sol Spf25 Lip Balm, a human over the counter drug labeled by Guangzhou Fantesy Biotechnology Co.,ltd. This paste is formulated for topical 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 August 09, 2024. 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: 83447000901. 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)
83447-009-01
11-Digit CMS (5-4-2)
83447-0009-01

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