Eb-5 Super Hydrating Anti-aging Spf-50 Cream
NDC Package 84060-439-00

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

Package Information

Eb-5 Super Hydrating Anti-aging Spf-50 (octocrylene, zinc oxide, octisalate) cream is apply liberally all over the face, neck and chest 15 minutes before sun exposure. This formulation utilizes a cream delivery system. Marketed by Life O, Inc., this product is identified by NDC 84060-439 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
84060-439-00
Package Description
1 TUBE in 1 BOX / 50 mL in 1 TUBE
Product Code
84060-439
11-Digit Billing Format
84060043900

Clinical Specifications

Proprietary Name
Eb-5 Super Hydrating Anti-aging Spf-50
Non-Proprietary Name
Octocrylene, Zinc Oxide, Octisalate
Substance Name
Octisalate; Octocrylene; Zinc Oxide
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
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)
Pharmacologic Class
Usage Information
Apply liberally all over the face, neck and chest 15 minutes before sun exposure. To maintain original protection, reapply every 2 hours. Use every morning as the last step in your daily skincare regime. Can be used alone or under make-up. Can also be used on full body.Children under 6 months of age: ask a doctor.Use a water -resistant sunscreen if swimming or sweatingSun Protection MeasuresSp ending 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 10 a.m.-2 p.m.Wear long-sleeved shirts, pants, hats, and sunglasses.

Regulatory & Marketing

Labeler Name
Life O, Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-26-2023
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 84060-439-00 identifies a specific commercial package of 1 tube in 1 box / 50 ml in 1 tube of Eb-5 Super Hydrating Anti-aging Spf-50, a human over the counter drug labeled by Life O, Inc.. This cream is formulated for topical use and contains octisalate; octocrylene; zinc oxide 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 Life O, Inc. on December 26, 2023. The current certification is valid through December 31, 2026.

How is this Life O, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84060043900. 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)
84060-439-00
11-Digit CMS (5-4-2)
84060-0439-00

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