Naked Sundays Poutscreen Plumping Lip Treatment Marshmallow 10ml Liquid
NDC Package 81104-249-01

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

Package Information

Naked Sundays Poutscreen Plumping Lip Treatment Marshmallow 10ml (lip treatment) liquids is sPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.Reapply after 80 minutes of swimming or sweating.Reapply immediately after towel drying.Reapply at least every 2 hours.Children under 3 years of age: Ask a doctor.SUN PROTECTION MEASURES:Spending time in the sun increases your risk of skin cancer and early skin aging. This formulation utilizes a liquid delivery system. Marketed by Naked Sundays Pty Ltd, this product is identified by NDC 81104-249 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
81104-249-01
Package Description
10 mL in 1 TUBE, WITH APPLICATOR
Product Code
81104-249
11-Digit Billing Format
81104024901

Clinical Specifications

Proprietary Name
Naked Sundays Poutscreen Plumping Lip Treatment Marshmallow 10ml
Non-Proprietary Name
Lip Treatment
Substance Name
Avobenzone; Homosalate; Octisalate; Octocrylene
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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
SPRAY 7 TIMES WITH MOUTH AND LIPS CLOSED 8-10" AWAY FROM FACE 15 MINUTES BEFORE SUN EXPOSURE.Reapply after 80 minutes of swimming or sweating.Reapply immediately after towel drying.Reapply at least every 2 hours.Children under 3 years of age: Ask a doctor.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 10.00AM - 2.00PMWear long-sleeved shirts, pants, hats, and sunglasses

Regulatory & Marketing

Labeler Name
Naked Sundays Pty Ltd
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-16-2024
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 81104-249-01 identifies a specific commercial package of 10 ml in 1 tube, with applicator of Naked Sundays Poutscreen Plumping Lip Treatment Marshmallow 10ml, a human over the counter drug labeled by Naked Sundays Pty Ltd. This liquid is formulated for topical use and contains avobenzone; homosalate; octisalate; octocrylene 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 Naked Sundays Pty Ltd on October 16, 2024. The current certification is valid through December 31, 2026.

How is this Naked Sundays Pty Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81104024901. 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)
81104-249-01
11-Digit CMS (5-4-2)
81104-0249-01

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