(re) Setting 100% Mineral Powder Light Broad Spectrum Spf 35 Powder
NDC Package 75936-166-01

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

(re) Setting 100% Mineral Powder Light Broad Spectrum Spf 35 (zinc oxide) powders is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a powder delivery system. Marketed by Supergoop, Llc, this product is identified by NDC 75936-166 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
75936-166-01
Package Description
4.25 g in 1 BOTTLE
Product Code
75936-166
11-Digit Billing Format
75936016601

Clinical Specifications

Proprietary Name
(re) Setting 100% Mineral Powder Light Broad Spectrum Spf 35
Non-Proprietary Name
Zinc Oxide
Substance Name
Zinc Oxide
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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 24.7 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
Supergoop, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-08-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (75936-166). Click a package code to view its specific billing and regulatory data.

75936-166-02
4.25 g in 1 JAR

* 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 75936-166-01 identifies a specific commercial package of 4.25 g in 1 bottle of (re) Setting 100% Mineral Powder Light Broad Spectrum Spf 35, a human over the counter drug labeled by Supergoop, Llc. This powder 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 Supergoop, Llc on September 08, 2020. 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 Supergoop, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75936016601. 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)
75936-166-01
11-Digit CMS (5-4-2)
75936-0166-01

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