Jafra Royal Revitalize 4 Tube Set Kit
NDC Package 68828-522-01

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

Package Information

Jafra Royal Revitalize 4 Tube Set (avobenzone, homosalate, octisalate, octocrylene) kits is apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hours.children under 6 months of age: Ask a doctorSun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. This formulation utilizes a kit delivery system. Marketed by Distribuidora Comercial Jafra, S.a. De C.v., this product is identified by NDC 68828-522 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
68828-522-01
Package Description
1 KIT in 1 KIT * 7.5 mL in 1 TUBE * 14 mL in 1 TUBE * 14 mL in 1 TUBE (68828-523-01) * 30 mL in 1 TUBE
Product Code
68828-522
11-Digit Billing Format
68828052201

Clinical Specifications

Proprietary Name
Jafra Royal Revitalize 4 Tube Set
Non-Proprietary Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage Form
Kit - A packaged collection of related material.
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.
Usage Information
Apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hours.children under 6 months of age: Ask a doctorSun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:         • limit your time in the sun, especially from 10 a.m. – 2 p.m.        • wear long-sleeved shirts, pants, hats, and sunglasses

Regulatory & Marketing

Labeler Name
Distribuidora Comercial Jafra, S.a. De C.v.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-20-2024
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 68828-522-01 identifies a specific commercial package of 1 kit in 1 kit * 7.5 ml in 1 tube * 14 ml in 1 tube * 14 ml in 1 tube (68828-523-01) * 30 ml in 1 tube of Jafra Royal Revitalize 4 Tube Set, a human over the counter drug labeled by Distribuidora Comercial Jafra, S.a. De C.v.. This kit is formulated for topical use and contains 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 Distribuidora Comercial Jafra, S.a. De C.v. on December 20, 2024. The current certification is valid through December 31, 2026.

How is this Distribuidora Comercial Jafra, S.a. De C.v. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68828052201. 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)
68828-522-01
11-Digit CMS (5-4-2)
68828-0522-01

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