The Tinted Serum Broad Spectrum Spf 50
NDC Package 83108-001-00

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

The Tinted Serum Broad Spectrum Spf 50 is apply liberally 15 minutes before sun exposure.Reapply At least every 2 hours Use a water resistant sunscreen if swimming or sweating.Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin ageing. Marketed by Rationale Group Pty Ltd, this product is identified by NDC 83108-001 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
83108-001-00
Package Description
1 BOTTLE, DROPPER in 1 BOX / 30 mL in 1 BOTTLE, DROPPER
Product Code
83108-001
11-Digit Billing Format
83108000100

Clinical Specifications

Proprietary Name
The Tinted Serum Broad Spectrum Spf 50
Dosage Form
-
Usage Information
Apply liberally 15 minutes before sun exposure.Reapply At least every 2 hours Use a water resistant sunscreen if swimming or sweating.Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin ageing. 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 from 10 a.m -2p.m.Wear long sleeved shirts, pants, hats and sunglasses.Children under 6 months of age: Ask a doctor. 

Regulatory & Marketing

Labeler Name
Rationale Group Pty Ltd
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-25-2022
End Marketing Date
09-01-2026
Listing Expiration
09-01-2026
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (83108-001). Click a package code to view its specific billing and regulatory data.

83108-001-03
3 mL in 1 BOTTLE, DROPPER
83108-001-05
5 mL in 1 BOTTLE, DROPPER
83108-001-13
3 mL in 1 BOTTLE
83108-001-15
5 mL in 1 BOTTLE

* 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 83108-001-00 identifies a specific commercial package of 1 bottle, dropper in 1 box / 30 ml in 1 bottle, dropper of The Tinted Serum Broad Spectrum Spf 50, labeled by Rationale Group 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 Rationale Group Pty Ltd on November 25, 2022. The current certification is valid through September 01, 2026.

How is this Rationale Group Pty Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83108000100. 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)
83108-001-00
11-Digit CMS (5-4-2)
83108-0001-00

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