The Tinted Serum Broad Spectrum Spf 50 Emulsion
NDC Package 83108-001-05

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

The Tinted Serum Broad Spectrum Spf 50 (zinc oxide) emulsions is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a emulsion delivery system. 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
83108-001-05
Package Description
5 mL in 1 BOTTLE, DROPPER
Product Code
83108-001
11-Digit Billing Format
83108000105

Clinical Specifications

Proprietary Name
The Tinted Serum Broad Spectrum Spf 50
Non-Proprietary Name
Zinc Oxide
Substance Name
Zinc Oxide
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
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 240 mg/mL
Pharmacologic Class
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
Rationale Group Pty Ltd
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-25-2022
End Marketing Date
09-01-2026
Exclude Flag
N
Sample Package
Yes

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.

83108-001-00
1 BOTTLE, DROPPER in 1 BOX / 30 mL in 1 BOTTLE, DROPPER
83108-001-03
3 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 83108-001-05 identifies a specific commercial package of 5 ml in 1 bottle, dropper of The Tinted Serum Broad Spectrum Spf 50, a human over the counter drug labeled by Rationale Group Pty Ltd. This emulsion 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 Rationale Group Pty Ltd on November 25, 2022.

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 Rationale Group Pty Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83108000105. 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)
83108-001-05
11-Digit CMS (5-4-2)
83108-0001-05

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