Maximum Repair Spf 50 Cream
NDC Package 84178-008-01

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

Package Information

Maximum Repair Spf 50 (spf 50) cream is apply liberally 15 minutes before sun exposure.At least, every two hours.Immediately after swimming, sweating, or towel drying. This formulation utilizes a cream delivery system. Marketed by Evi Labs, this product is identified by NDC 84178-008 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
84178-008-01
Package Description
1 BOTTLE, PUMP in 1 BOX / 48 g in 1 BOTTLE, PUMP
Product Code
84178-008
11-Digit Billing Format
84178000801

Clinical Specifications

Proprietary Name
Maximum Repair Spf 50 Broad Spectrum
Non-Proprietary Name
Spf 50
Substance Name
Avobenzone; Homosalate; Octinoxate; Octisalate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Cutaneous - Administration to the skin.
Active Ingredient(s)
Usage Information
Apply liberally 15 minutes before sun exposure.At least, every two hours.Immediately after swimming, sweating, or towel drying.

Regulatory & Marketing

Labeler Name
Evi Labs
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-09-2024
Listing Expiration
12-31-2027
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 84178-008-01 identifies a specific commercial package of 1 bottle, pump in 1 box / 48 g in 1 bottle, pump of Maximum Repair Spf 50 Broad Spectrum, a human over the counter drug labeled by Evi Labs. This cream is formulated for cutaneous use and contains avobenzone; homosalate; octinoxate; 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 Evi Labs on October 09, 2024. The current certification is valid through December 31, 2027.

How is this Evi Labs product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84178000801. 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)
84178-008-01
11-Digit CMS (5-4-2)
84178-0008-01

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