Samhealthyskin B.b. Sunscreen Broad Spectrum Spf 40
NDC Package 57650-159-79

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.

Samhealthyskin B.b. Sunscreen Broad Spectrum Spf 40 is for sunscreen useApply liberally 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingSun Protection Measures. Marketed by Samhealthyskin.com Llc, this product is identified by NDC 57650-159 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
57650-159-79
Package Description
50 mL in 1 BOTTLE, PUMP
Product Code
57650-159
11-Digit Billing Format
57650015979

Clinical Specifications

Proprietary Name
Samhealthyskin B.b. Sunscreen Broad Spectrum Spf 40
Dosage Form
-
Usage Information
For sunscreen useApply liberally 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingSun Protection Measures. Spending 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 SPF value 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 sunglassesChildren under 6 months of age: Ask a doctor

Regulatory & Marketing

Labeler Name
Samhealthyskin.com 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
04-25-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 57650-159-79 identifies a specific commercial package of 50 ml in 1 bottle, pump of Samhealthyskin B.b. Sunscreen Broad Spectrum Spf 40, labeled by Samhealthyskin.com 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 Samhealthyskin.com Llc on April 25, 2013. The current certification is valid through December 31, 2017.

How is this Samhealthyskin.com Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57650015979. 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)
57650-159-79
11-Digit CMS (5-4-2)
57650-0159-79

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