Intelligent Elixirs Tinted Broad Spectrum Spf 30 - Tan Lotion
NDC Package 84977-0033-1

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

Package Information

Intelligent Elixirs Tinted Broad Spectrum Spf 30 - Tan (avobenzone, octisalate, octinoxate) lotions is apply 15 minutes before sun exposure and as needed. This formulation utilizes a lotion delivery system. Marketed by Intelligent Elixirs, Llc, this product is identified by NDC 84977-0033 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
84977-0033-1
Package Description
1 TUBE in 1 CARTON / 51 mL in 1 TUBE
Product Code
84977-0033
11-Digit Billing Format
84977003301

Clinical Specifications

Proprietary Name
Intelligent Elixirs Tinted Broad Spectrum Spf 30 - Tan
Non-Proprietary Name
Avobenzone, Octisalate, Octinoxate
Substance Name
Avobenzone; Octinoxate; Octisalate
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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 15 minutes before sun exposure and as needed. Reapply at least every 2 hours. Use water resistant sunscreen if swimming or sweating.Consult with doctor before use on children under 6 months. Sun protection measures. Spending time in the sun increases risk of skin cancer and early skin aging. To decrease this risk, regularly use a broad spectrum SPF of 15 or higher, including: limit time in sun, especially from 10am-2pm, wear long sleeve shirts, pants, hats and sunglasses.

Regulatory & Marketing

Labeler Name
Intelligent Elixirs, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-04-2024
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 84977-0033-1 identifies a specific commercial package of 1 tube in 1 carton / 51 ml in 1 tube of Intelligent Elixirs Tinted Broad Spectrum Spf 30 - Tan, a human over the counter drug labeled by Intelligent Elixirs, Llc. This lotion is formulated for topical use and contains avobenzone; octinoxate; 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 Intelligent Elixirs, Llc on December 04, 2024. The current certification is valid through December 31, 2026.

How is this Intelligent Elixirs, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84977003301. 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 (5-4-1)
84977-0033-1
11-Digit CMS (5-4-2)
84977-0033-01

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