Mineral Sunscreen Lip Balm Spf 15 Lipstick
NDC Package 53675-184-17

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

Package Information

Mineral Sunscreen Lip Balm Spf 15 (titanium dioxide, zinc oxide) lipsticks is a medication used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). This formulation utilizes a lipstick delivery system. Marketed by Aruba Aloe Balm Nv, this product is identified by NDC 53675-184 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
53675-184-17
Package Description
4.8 g in 1 APPLICATOR
Product Code
53675-184
11-Digit Billing Format
53675018417

Clinical Specifications

Proprietary Name
Mineral Sunscreen Lip Balm Spf 15
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
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)
ZINC OXIDE 80 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

Regulatory & Marketing

Labeler Name
Aruba Aloe Balm Nv
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-05-2019
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 53675-184-17 identifies a specific commercial package of 4.8 g in 1 applicator of Mineral Sunscreen Lip Balm Spf 15, a human over the counter drug labeled by Aruba Aloe Balm Nv. This lipstick is formulated for topical use and contains 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 Aruba Aloe Balm Nv on January 05, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

How is this Aruba Aloe Balm Nv product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53675018417. 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)
53675-184-17
11-Digit CMS (5-4-2)
53675-0184-17

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