Tatcha The Kissu Lip Tint Spf 25 Midnight Lily Lipstick
NDC Package 69417-161-01

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

Package Information

Tatcha The Kissu Lip Tint Spf 25 Midnight Lily (octisalate, zinc oxide) lipsticks is • Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating• Reapply at least every 2 hours• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. This formulation utilizes a lipstick delivery system. Marketed by Tatcha Inc., this product is identified by NDC 69417-161 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
69417-161-01
Package Description
1 TUBE in 1 CARTON / 4 g in 1 TUBE
Product Code
69417-161
11-Digit Billing Format
69417016101

Clinical Specifications

Proprietary Name
Tatcha The Kissu Lip Tint Spf 25 Midnight Lily
Non-Proprietary Name
Octisalate, Zinc Oxide
Substance Name
Octisalate; Zinc Oxide
Dosage Form
Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.
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. • Use a water resistant sunscreen if swimming or sweating• Reapply at least every 2 hours• 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 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 sunglasses.• Children under 6 months: Ask a doctor.

Regulatory & Marketing

Labeler Name
Tatcha Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-12-2024
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 69417-161-01 identifies a specific commercial package of 1 tube in 1 carton / 4 g in 1 tube of Tatcha The Kissu Lip Tint Spf 25 Midnight Lily, a human over the counter drug labeled by Tatcha Inc.. This lipstick is formulated for topical use and contains 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 Tatcha Inc. on March 12, 2024. The current certification is valid through December 31, 2026.

How is this Tatcha Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69417016101. 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)
69417-161-01
11-Digit CMS (5-4-2)
69417-0161-01

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