Gleam Plus Glow Spf 50. Lotion
NDC Package 49358-581-01

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

Package Information

Gleam Plus Glow Spf 50. (avobenzone, octisalate, and octocrylene) lotions 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. This formulation utilizes a lotion delivery system. Marketed by Mdsolarsciences, this product is identified by NDC 49358-581 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
49358-581-01
Package Description
1 BOTTLE, PUMP in 1 CARTON / 50 mL in 1 BOTTLE, PUMP
Product Code
49358-581
11-Digit Billing Format
49358058101

Clinical Specifications

Proprietary Name
Gleam Plus Glow Spf 50. Spf 50 Broad Spectrum Sunscreen Uva-uvb Sheer Glow Tint
Non-Proprietary Name
Avobenzone, Octisalate, And Octocrylene
Substance Name
Avobenzone; Octisalate; Octocrylene
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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 49358-581-01 identifies a specific commercial package of 1 bottle, pump in 1 carton / 50 ml in 1 bottle, pump of Gleam Plus Glow Spf 50. Spf 50 Broad Spectrum Sunscreen Uva-uvb Sheer Glow Tint, a human over the counter drug labeled by Mdsolarsciences. This lotion is formulated for topical use and contains avobenzone; octisalate; octocrylene 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: 49358058101. 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)
49358-581-01
11-Digit CMS (5-4-2)
49358-0581-01

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