Hydrating Sheer Lip Balm Spf 30 - Shimmer Lipstick
NDC Package 49358-604-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hydrating Sheer Lip Balm Spf 30 - Shimmer (avobenzone, octisalate, and homosalate) lipsticks is apply liberally 15 minutes before sun exposureReapply:use a water resistant sunscreen if swimming or sweatingat least every 2 hoursChildren under 6 months: Ask a doctorSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:Limit time in the sun, especially from 10a.m.- 2p.m.Wear long-sleeved shirts, pants, hats and sunglasses. This formulation utilizes a lipstick delivery system. Marketed by Mdsolarsciences, this product is identified by NDC 49358-604 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
49358-604-01
Package Description
1 APPLICATOR in 1 CARTON / 4.2 g in 1 APPLICATOR
Product Code
49358-604
11-Digit Billing Format
49358060401

Clinical Specifications

Proprietary Name
Hydrating Sheer Lip Balm Spf 30 - Shimmer Broad Spectrum Spf 30 Uva-uvb Sunscreen
Non-Proprietary Name
Avobenzone, Octisalate, And Homosalate
Substance Name
Avobenzone; Homosalate; Octisalate
Dosage Form
Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
Apply liberally 15 minutes before sun exposureReapply:use a water resistant sunscreen if swimming or sweatingat least every 2 hoursChildren under 6 months: Ask a doctorSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection 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
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2023
Listing Expiration
12-31-2026
Exclude Flag
N
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 49358-604-01 identifies a specific commercial package of 1 applicator in 1 carton / 4.2 g in 1 applicator of Hydrating Sheer Lip Balm Spf 30 - Shimmer Broad Spectrum Spf 30 Uva-uvb Sunscreen, a human over the counter drug labeled by Mdsolarsciences. This lipstick is formulated for topical use and contains avobenzone; homosalate; octisalate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mdsolarsciences on July 01, 2023. The current certification is valid through December 31, 2026.

How is this Mdsolarsciences product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49358060401. 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)
49358-604-01
11-Digit CMS (5-4-2)
49358-0604-01

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