Groomwell Weightless With Mineral Broad Spectrum Spf 15 Sunscreen Cream
NDC Package 42508-827-23

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 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.

Groomwell Weightless With Mineral Broad Spectrum Spf 15 Sunscreen (zinc oxide) cream is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a cream delivery system. Marketed by Arbonne International, Llc, this product is identified by NDC 42508-827 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
42508-827-23
Package Description
1 JAR in 1 CARTON / 50 g in 1 JAR
Product Code
42508-827
11-Digit Billing Format
42508082723

Clinical Specifications

Proprietary Name
Groomwell Weightless With Mineral Broad Spectrum Spf 15 Sunscreen
Non-Proprietary Name
Zinc Oxide
Substance Name
Zinc Oxide
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the 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 49.5 mg/g
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
Arbonne International, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-27-2021
End Marketing Date
07-26-2026
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 42508-827-23 identifies a specific commercial package of 1 jar in 1 carton / 50 g in 1 jar of Groomwell Weightless With Mineral Broad Spectrum Spf 15 Sunscreen, a human over the counter drug labeled by Arbonne International, Llc. This cream 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 Arbonne International, Llc on April 27, 2021.

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 Arbonne International, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42508082723. 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)
42508-827-23
11-Digit CMS (5-4-2)
42508-0827-23

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