Made Of Broad Spectrum Spf 30 Non-nano Zinc Oxide Sunscreen
NDC Package 71439-050-16

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.

Made Of Broad Spectrum Spf 30 Non-nano Zinc Oxide Sunscreen is diretions for full protection, apply liberally (2mg/cm2) to all exposed skin 15 minutes before sun exposure then rub it in to reduce whitening effect.Reapply:After 40 minutes of swimming or sweating • Immediately after towel drying. Marketed by Madeof, Llc, this product is identified by NDC 71439-050 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
71439-050-16
Package Description
1 TUBE in 1 CARTON / 118 mL in 1 TUBE
Product Code
71439-050
11-Digit Billing Format
71439005016

Clinical Specifications

Proprietary Name
Made Of Broad Spectrum Spf 30 Non-nano Zinc Oxide Sunscreen
Dosage Form
-
Usage Information
Diretions for full protection, apply liberally (2mg/cm2) to all exposed skin 15 minutes before sun exposure then rub it in to reduce whitening effect.Reapply:After 40 minutes of swimming or sweating • Immediately after towel drying. • At least every two hours.Sun Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin agingTo decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pmWear long-sleeved shirts, pants, hats, and sunglassesFor children under six months of age ask a doctor.

Regulatory & Marketing

Labeler Name
Madeof, Llc
FDA Application #
part352
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
09-05-2017
Listing Expiration
12-31-2022
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 71439-050-16 identifies a specific commercial package of 1 tube in 1 carton / 118 ml in 1 tube of Made Of Broad Spectrum Spf 30 Non-nano Zinc Oxide Sunscreen, labeled by Madeof, Llc. 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 Madeof, Llc on September 05, 2017. The current certification is valid through December 31, 2022.

How is this Madeof, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71439005016. 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)
71439-050-16
11-Digit CMS (5-4-2)
71439-0050-16

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