Moisturizing Sunscreen Spf 30 Lotion
NDC Package 11344-559-34

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

Package Information

Moisturizing Sunscreen Spf 30 (avobenzone, homosalate, octisalate) lotions is apply liberally 15 minutes before sun exposureapply to all skin exposed to the sunreapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat 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 lotion delivery system. Marketed by Nice-pak Products, Llc, this product is identified by NDC 11344-559 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
11344-559-34
Package Description
236 mL in 1 BOTTLE, PLASTIC
Product Code
11344-559
11-Digit Billing Format
11344055934

Clinical Specifications

Proprietary Name
Moisturizing Sunscreen Spf 30
Non-Proprietary Name
Avobenzone, Homosalate, Octisalate
Substance Name
Avobenzone; Homosalate; Octisalate
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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 exposureapply to all skin exposed to the sunreapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat 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 value 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-sleeved shirts, pants, hats and sunglasseschildren under 6 months of age: Ask a doctor

Regulatory & Marketing

Labeler Name
Nice-pak Products, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-03-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (11344-559). Click a package code to view its specific billing and regulatory data.

11344-559-05
207 mL in 1 TUBE

* 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 11344-559-34 identifies a specific commercial package of 236 ml in 1 bottle, plastic of Moisturizing Sunscreen Spf 30, a human over the counter drug labeled by Nice-pak Products, Llc. This lotion is formulated for topical use and contains avobenzone; homosalate; octisalate 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 Nice-pak Products, Llc on May 03, 2023. The current certification is valid through December 31, 2027.

How is this Nice-pak Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11344055934. 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)
11344-559-34
11-Digit CMS (5-4-2)
11344-0559-34

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