Aloe Up Medicated Lip Balm Lipstick
NDC Package 61477-224-11

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

Package Information

Aloe Up Medicated Lip Balm (avobenzone, homosalate, octisalate, octocrylene, oxybenzone) lipsticks is • Apply liberally 15 minutes before sun exposure• Use a water resistant sunscreen if swimming or sweating• Reapply at least every 2 hours• Children under 6 months: Ask a doctor. This formulation utilizes a lipstick delivery system. Marketed by Aloe Care International, Llc, this product is identified by NDC 61477-224 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
61477-224-11
Package Description
4.25 g in 1 TUBE
Product Code
61477-224
11-Digit Billing Format
61477022411

Clinical Specifications

Proprietary Name
Aloe Up Medicated Lip Balm Spf 30
Non-Proprietary Name
Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Substance Name
Avobenzone; Homosalate; Octisalate; Octocrylene; Oxybenzone
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• Children under 6 months: Ask a doctor

Regulatory & Marketing

Labeler Name
Aloe Care International, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-17-2019
Listing Expiration
12-31-2027
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 61477-224-11 identifies a specific commercial package of 4.25 g in 1 tube of Aloe Up Medicated Lip Balm Spf 30, a human over the counter drug labeled by Aloe Care International, Llc. This lipstick is formulated for topical use and contains avobenzone; homosalate; octisalate; octocrylene; oxybenzone 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 Aloe Care International, Llc on May 17, 2019. The current certification is valid through December 31, 2027.

How is this Aloe Care International, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61477022411. 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)
61477-224-11
11-Digit CMS (5-4-2)
61477-0224-11

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