Sunscreen Spf 50 Plus Broad Spectrum Uva Uvb Protection Cream
NDC Package 53675-165-00

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

Package Information

Sunscreen Spf 50 Plus Broad Spectrum Uva Uvb Protection (avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone) cream is apply generously 15 minutes before sun exposurereapplyafter 80 minutes of swimming of sweatingimmediately after towel dryingat least every 2 hoursSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. This formulation utilizes a cream delivery system. Marketed by Aruba Aloe Balm Nv, this product is identified by NDC 53675-165 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
53675-165-00
Package Description
59 mL in 1 TUBE
Product Code
53675-165
11-Digit Billing Format
53675016500

Clinical Specifications

Proprietary Name
Sunscreen Spf 50 Plus Broad Spectrum Uva Uvb Protection
Non-Proprietary Name
Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene, Oxybenzone
Substance Name
Avobenzone; Homosalate; Octinoxate; Octisalate; Octocrylene; Oxybenzone
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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 generously 15 minutes before sun exposurereapplyafter 80 minutes of swimming of sweatingimmediately after towel dryingat least every 2 hoursSun 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 andd other sun protection measures including: limit time in the sun, especially from 10 a.m.-2p.m.wear long-sleeved shirts, pants, hats, and sunglasseschildren under 6 months of age: Ask a doctor

Regulatory & Marketing

Labeler Name
Aruba Aloe Balm Nv
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-10-2017
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 53675-165-00 identifies a specific commercial package of 59 ml in 1 tube of Sunscreen Spf 50 Plus Broad Spectrum Uva Uvb Protection, a human over the counter drug labeled by Aruba Aloe Balm Nv. This cream is formulated for topical use and contains avobenzone; homosalate; octinoxate; 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 Aruba Aloe Balm Nv on June 10, 2017. The current certification is valid through December 31, 2027.

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: 53675016500. 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)
53675-165-00
11-Digit CMS (5-4-2)
53675-0165-00

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