Pro-tect Everyday Sunscreen Spf 15
NDC Package 61619-868-08

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Pro-tect Everyday Sunscreen Spf 15 is •Apply liberally and evenly on all exposed areas 20-30 minutes before exposure to the sun and as needed.•Children under 6 months of age: ask a doctor. Marketed by A-cute Derm, Incorporated, this product is identified by NDC 61619-868 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
61619-868-08
Package Description
236.6 g in 1 BOTTLE, PLASTIC
Product Code
61619-868
11-Digit Billing Format
61619086808

Clinical Specifications

Proprietary Name
Pro-tect Everyday Sunscreen Spf 15
Dosage Form
-
Usage Information
•Apply liberally and evenly on all exposed areas 20-30 minutes before exposure to the sun and as needed.•Children under 6 months of age: ask a doctor.

Regulatory & Marketing

Labeler Name
A-cute Derm, Incorporated
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
11-03-2015
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (61619-868). Click a package code to view its specific billing and regulatory data.

61619-868-04
118.3 g in 1 BOTTLE, PLASTIC
61619-868-07
29.6 g in 1 BOTTLE, PLASTIC
61619-868-28
3800 g in 1 BOTTLE, PLASTIC
61619-868-32
946.4 g in 1 BOTTLE, PLASTIC
61619-868-35
18900 g in 1 CONTAINER
61619-868-55
208200 g in 1 CONTAINER

* 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 61619-868-08 identifies a specific commercial package of 236.6 g in 1 bottle, plastic of Pro-tect Everyday Sunscreen Spf 15, labeled by A-cute Derm, Incorporated. 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 A-cute Derm, Incorporated on November 03, 2015. The current certification is valid through December 31, 2017.

How is this A-cute Derm, Incorporated product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61619086808. 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)
61619-868-08
11-Digit CMS (5-4-2)
61619-0868-08

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