Squalane Zinc Sheer Mineral Sunscreen
NDC Package 73517-125-01

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.

Squalane Zinc Sheer Mineral Sunscreen is helps prevent sunburnif used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early signs of aging caused by the sunWarningsFor external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyes Rinse with water to removeStop use and ask a doctor if rash occursKeep out of reach of children if product is swallwed get medical help or contact Poison Control Center right awayDirectionsapply generously 15 minutes before sun exposure. Marketed by Amyris, Inc, this product is identified by NDC 73517-125 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
73517-125-01
Package Description
50 mL in 1 TUBE
Product Code
73517-125
11-Digit Billing Format
73517012501

Clinical Specifications

Proprietary Name
Squalane Zinc Sheer Mineral Sunscreen
Dosage Form
-
Usage Information
Helps prevent sunburnif used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early signs of aging caused by the sunWarningsFor external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyes Rinse with water to removeStop use and ask a doctor if rash occursKeep out of reach of children if product is swallwed get medical help or contact Poison Control Center right awayDirectionsapply generously 15 minutes before sun exposure. reapply at least every 2 hoursSun Protection MeasuresSpendign 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 value of SPF 15 or higher and other sun protections measures including: limit time in the sun, especially from 10 am - 2pmwear long-sleeved shirts, pants, hats, and sunglassesuse a water resistant sunscreen if swimming or sweatingchildren under 6 months of age ask a doctor.

Regulatory & Marketing

Labeler Name
Amyris, Inc
FDA Application #
part352
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
04-01-2020
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 73517-125-01 identifies a specific commercial package of 50 ml in 1 tube of Squalane Zinc Sheer Mineral Sunscreen, labeled by Amyris, Inc. 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 Amyris, Inc on April 01, 2020. The current certification is valid through December 31, 2023.

How is this Amyris, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 73517012501. 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)
73517-125-01
11-Digit CMS (5-4-2)
73517-0125-01

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