Hydrating Sheer Lip Balm Spf 30 - Pink
NDC Package 49358-565-01

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.

Hydrating Sheer Lip Balm Spf 30 - Pink is apply liberally 15 minutes before sun exposure & again after swimming or sweating.Reapply at least every 2 hours.Children under 6 months: Ask a doctorSun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including:Limit time in the sun, especially from 10a.m.-2p.m.Wear long-sleeved shirts, pants, hats and sunglasses. Marketed by Mdsolarsciences, this product is identified by NDC 49358-565 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
49358-565-01
Package Description
1 APPLICATOR in 1 CARTON / 4.2 g in 1 APPLICATOR
Product Code
49358-565
11-Digit Billing Format
49358056501

Clinical Specifications

Proprietary Name
Hydrating Sheer Lip Balm Spf 30 - Pink Broad Spectrum Spf 30 Uva-uvb Sunscreen
Dosage Form
-
Usage Information
Apply liberally 15 minutes before sun exposure & again after swimming or sweating.Reapply at least every 2 hours.Children under 6 months: Ask a doctorSun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including:Limit time in the sun, especially from 10a.m.-2p.m.Wear long-sleeved shirts, pants, hats and sunglasses

Regulatory & Marketing

Labeler Name
Mdsolarsciences
FDA Application #
part352
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-01-2019
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 49358-565-01 identifies a specific commercial package of 1 applicator in 1 carton / 4.2 g in 1 applicator of Hydrating Sheer Lip Balm Spf 30 - Pink Broad Spectrum Spf 30 Uva-uvb Sunscreen, labeled by Mdsolarsciences. 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 Mdsolarsciences on October 01, 2019. The current certification is valid through December 31, 2022.

How is this Mdsolarsciences product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49358056501. 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)
49358-565-01
11-Digit CMS (5-4-2)
49358-0565-01

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