Standard Procedure Spf 50 Sunscreen Lotion
NDC Package 84425-101-04

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

Package Information

Standard Procedure Spf 50 Sunscreen (homosalate, octocrylene, octisalate, avobenzone) lotions is apply generously and evenly 15 minutes before sun exposure Reapply at least every 80 minutesUsa a water resistant sunscreen if swimming or sweatingSun Protection Measures. This formulation utilizes a lotion delivery system. Marketed by Standard Procedure Inc, this product is identified by NDC 84425-101 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
84425-101-04
Package Description
500 mL in 1 BOTTLE, PLASTIC
Product Code
84425-101
11-Digit Billing Format
84425010104

Clinical Specifications

Proprietary Name
Standard Procedure Spf 50 Sunscreen
Non-Proprietary Name
Homosalate, Octocrylene, Octisalate, Avobenzone
Substance Name
Avobenzone; Homosalate; 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 generously and evenly 15 minutes before sun exposure Reapply at least every 80 minutesUsa a water resistant sunscreen if swimming or sweatingSun Protection Measures. Speading time in the sun increases your risk of skin cancer and early skin aging. To decres this risk, regularly usa a sunscreen with broad spectum SPF of 15 or higher and other sun protection measures including: Limit time in thee sun, especially from 10 a.m. - 2 p.m, wear long-sleeve shirts, pants, hats and sunglasses, children under 6 months: Ask a doctor

Regulatory & Marketing

Labeler Name
Standard Procedure Inc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (84425-101). Click a package code to view its specific billing and regulatory data.

84425-101-01
60 mL in 1 BOTTLE, PLASTIC
84425-101-03
250 mL in 1 BOTTLE, PLASTIC

* 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 84425-101-04 identifies a specific commercial package of 500 ml in 1 bottle, plastic of Standard Procedure Spf 50 Sunscreen, a human over the counter drug labeled by Standard Procedure Inc. This lotion is formulated for topical use and contains avobenzone; homosalate; 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 Standard Procedure Inc on July 15, 2024. The current certification is valid through December 31, 2027.

How is this Standard Procedure Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84425010104. 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)
84425-101-04
11-Digit CMS (5-4-2)
84425-0101-04

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