Tan De Soleil Orange Tanning Balm Spf 6 Oil
NDC Package 84562-509-00

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

Package Information

Tan De Soleil Orange Tanning Balm Spf 6 (homosalate, octisalate) oils is apply liberally 15 minutes before sun exposure and as needed.Children under 6 months of age: ask a doctor.Reapply at least every 2 hoursUse a water-resistant sunscreen if swimming or sweatingSun Protection Measures. Spending 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. This formulation utilizes a oil delivery system. Marketed by Tanning Club, Llc, this product is identified by NDC 84562-509 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
84562-509-00
Package Description
1 TUBE in 1 BOX / 100 mL in 1 TUBE
Product Code
84562-509
11-Digit Billing Format
84562050900

Clinical Specifications

Proprietary Name
Tan De Soleil Orange Tanning Balm Spf 6
Non-Proprietary Name
Homosalate, Octisalate
Substance Name
Homosalate; Octisalate
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
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 liberally 15 minutes before sun exposure and as needed.Children under 6 months of age: ask a doctor.Reapply at least every 2 hoursUse a water-resistant sunscreen if swimming or sweatingSun Protection Measures. Spending 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
Tanning Club, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2024
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 84562-509-00 identifies a specific commercial package of 1 tube in 1 box / 100 ml in 1 tube of Tan De Soleil Orange Tanning Balm Spf 6, a human over the counter drug labeled by Tanning Club, Llc. This oil is formulated for topical use and contains homosalate; octisalate 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 Tanning Club, Llc on July 01, 2024. The current certification is valid through December 31, 2026.

How is this Tanning Club, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84562050900. 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)
84562-509-00
11-Digit CMS (5-4-2)
84562-0509-00

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