Tom Ford Architecture Radiance Hydrating Foundation Broad Spectrum Spf 50 Emulsion
NDC Package 76398-015-01

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

Package Information

Tom Ford Architecture Radiance Hydrating Foundation Broad Spectrum Spf 50 (ensulizole, octinoxate, octisalate, and zinc oxide) emulsions is for sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. This formulation utilizes a emulsion delivery system. Marketed by Tom Ford Beauty Dist, this product is identified by NDC 76398-015 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
76398-015-01
Package Description
1 BOTTLE, PUMP in 1 CARTON / 30 mL in 1 BOTTLE, PUMP
Product Code
76398-015
11-Digit Billing Format
76398001501

Clinical Specifications

Proprietary Name
Tom Ford Architecture Radiance Hydrating Foundation Broad Spectrum Spf 50
Non-Proprietary Name
Ensulizole, Octinoxate, Octisalate, And Zinc Oxide
Substance Name
Ensulizole; Octinoxate; Octisalate; Zinc Oxide
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 exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating Sun 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 time in the sun, especially from 10 a.m.–2 p.m. wear long-sleeved shirts, pants, hats and sunglasses children under 6 months of age: ask a doctor

Regulatory & Marketing

Labeler Name
Tom Ford Beauty Dist
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-06-2024
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 76398-015-01 identifies a specific commercial package of 1 bottle, pump in 1 carton / 30 ml in 1 bottle, pump of Tom Ford Architecture Radiance Hydrating Foundation Broad Spectrum Spf 50, a human over the counter drug labeled by Tom Ford Beauty Dist. This emulsion is formulated for topical use and contains ensulizole; octinoxate; octisalate; 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 Tom Ford Beauty Dist on December 06, 2024. The current certification is valid through December 31, 2026.

How is this Tom Ford Beauty Dist product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76398001501. 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)
76398-015-01
11-Digit CMS (5-4-2)
76398-0015-01

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