Sunny Skin Glow Filter Spf50
NDC Package 83070-002-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Sunny Skin Glow Filter Spf50 is for sunscreen use: • apply liberally 15 mins before sun exposure • apply to all skin exposed to the sun • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours. Marketed by Mcdonald Multinational Pty Ltd, this product is identified by NDC 83070-002 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
83070-002-01
Package Description
1 TUBE in 1 BOX / 50 mL in 1 TUBE
Product Code
83070-002
11-Digit Billing Format
83070000201

Clinical Specifications

Proprietary Name
Sunny Skin Glow Filter Spf50
Dosage Form
-
Usage Information
For sunscreen use: • apply liberally 15 mins before sun exposure • apply to all skin exposed to the sun • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours. Children under 6 months old of age: ask doctor. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses.

Regulatory & Marketing

Labeler Name
Mcdonald Multinational Pty Ltd
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
10-27-2022
Listing Expiration
12-31-2023
Exclude Flag
I
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 83070-002-01 identifies a specific commercial package of 1 tube in 1 box / 50 ml in 1 tube of Sunny Skin Glow Filter Spf50, labeled by Mcdonald Multinational Pty Ltd. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mcdonald Multinational Pty Ltd on October 27, 2022. The current certification is valid through December 31, 2023.

How is this Mcdonald Multinational Pty Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83070000201. 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)
83070-002-01
11-Digit CMS (5-4-2)
83070-0002-01

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