Mineral Sunscreen Spf-30 Liquid
NDC Package 83387-399-00

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

Package Information

Mineral Sunscreen Spf-30 (titanium dioxide, zinc oxide) liquids is • Apply liberally 15 minutes before sun exposure and as needed. This formulation utilizes a liquid delivery system. Marketed by Newco Llc, this product is identified by NDC 83387-399 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
83387-399-00
Package Description
177 mL in 1 BOTTLE, SPRAY
Product Code
83387-399
11-Digit Billing Format
83387039900

Clinical Specifications

Proprietary Name
Mineral Sunscreen Spf-30
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; Zinc Oxide
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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)
Pharmacologic Class
Usage Information
• Apply liberally 15 minutes before sun exposure and as needed. • Children under 6 months of age: Ask a doctor. Reapply:• After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

Regulatory & Marketing

Labeler Name
Newco Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-17-2023
Listing Expiration
12-31-2026
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 83387-399-00 identifies a specific commercial package of 177 ml in 1 bottle, spray of Mineral Sunscreen Spf-30, a human over the counter drug labeled by Newco Llc. This liquid is formulated for topical use and contains titanium dioxide; 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 Newco Llc on April 17, 2023. The current certification is valid through December 31, 2026.

How is this Newco Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83387039900. 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)
83387-399-00
11-Digit CMS (5-4-2)
83387-0399-00

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