Cle De Peau Beaute Radiant Fluid Foundation Natural Emulsion
NDC Package 58411-921-20

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

Package Information

Cle De Peau Beaute Radiant Fluid Foundation Natural (octinoxate and titanium dioxide) emulsions is for sunscreen use:apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hoursSun Protection Measures. This formulation utilizes a emulsion delivery system. Marketed by Shiseido Americas Corporation, this product is identified by NDC 58411-921 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
58411-921-20
Package Description
35 VIAL in 1 CARTON / 35 mL in 1 VIAL (58411-921-70)
Product Code
58411-921
11-Digit Billing Format
58411092120

Clinical Specifications

Proprietary Name
Cle De Peau Beaute Radiant Fluid Foundation Natural O50
Non-Proprietary Name
Octinoxate And Titanium Dioxide
Substance Name
Octinoxate; Titanium Dioxide
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
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
For sunscreen use:apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hoursSun 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 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-sleeve shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctor

Regulatory & Marketing

Labeler Name
Shiseido Americas Corporation
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2021
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 58411-921-20 identifies a specific commercial package of 35 vial in 1 carton / 35 ml in 1 vial (58411-921-70) of Cle De Peau Beaute Radiant Fluid Foundation Natural O50, a human over the counter drug labeled by Shiseido Americas Corporation. This emulsion is formulated for topical use and contains octinoxate; titanium dioxide 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 Shiseido Americas Corporation on January 01, 2021. The current certification is valid through December 31, 2027.

How is this Shiseido Americas Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58411092120. 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)
58411-921-20
11-Digit CMS (5-4-2)
58411-0921-20

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