Soleil Broad Spectrum Spf-50
NDC Package 69630-003-50

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.

Soleil Broad Spectrum Spf-50 is apply liberally 20 minutes prior to sunexposure. Marketed by The Soleil Group, Llc, this product is identified by NDC 69630-003 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
69630-003-50
Package Description
177.4 mL in 1 BOTTLE, SPRAY
Product Code
69630-003
11-Digit Billing Format
69630000350

Clinical Specifications

Proprietary Name
Soleil Broad Spectrum Spf-50
Dosage Form
-
Usage Information
Apply liberally 20 minutes prior to sunexposure. Do not spray onto face. Spray into hands and applyto face. Use in well-ventilated areas. Reapply: immediatelyafter swimming, sweating or towel drying and at least every 2hours. Sun Protection Measures. Spending time in the sunincreases your risk of skin cancer and early skin aging. Todecrease this risk, regularly use a sunscreen with a broadspectrum SPF of 15 or higher and other sun protectionmeasures including: Limit time in the sun, especially from 10a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats andsunglasses. Children under 6 months: Ask a doctor.

Regulatory & Marketing

Labeler Name
The Soleil Group, Llc
FDA Application #
part352
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-13-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69630-003-50 identifies a specific commercial package of 177.4 ml in 1 bottle, spray of Soleil Broad Spectrum Spf-50, labeled by The Soleil Group, 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 The Soleil Group, Llc on February 13, 2015. The current certification is valid through December 31, 2017.

How is this The Soleil Group, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69630000350. 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)
69630-003-50
11-Digit CMS (5-4-2)
69630-0003-50

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