Ocean Potion Suncare 30 Continuous Sunscreen Scent Of Sunshine Spray
NDC Package 85638-003-37

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

Package Information

Ocean Potion Suncare 30 Continuous Sunscreen Scent Of Sunshine (avobenzone, homosalate, octisalate, octocrylene) sprays is • Spray liberally and spread evenly by hand 15 minutes before sun exposure• Hold can 4-6 inches away from the skin to apply• Do not spray directly into face. This formulation utilizes a spray delivery system. Marketed by Gnl Brands International, Llc, this product is identified by NDC 85638-003 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
85638-003-37
Package Description
156 g in 1 CAN
Product Code
85638-003
11-Digit Billing Format
85638000337

Clinical Specifications

Proprietary Name
Ocean Potion Suncare 30 Continuous Sunscreen Scent Of Sunshine
Non-Proprietary Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Substance Name
Avobenzone; Homosalate; Octisalate; Octocrylene
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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 liberally and spread evenly by hand 15 minutes before sun exposure• Hold can 4-6 inches away from the skin to apply• Do not spray directly into face. Spray into hands then apply to face• Do not apply in windy conditions• Use in a well-ventilated area• reapply:• after 80 minutes of swimming or sweating• immediately after towel drying• at least every 2 hours• children under 6 months of age: Ask a doctor• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Todecrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protectionmeasures including:• limit time in the sun, especially from 10 a.m. - 2 p.m.• wear long-sleeved shirts, pants, hats, and sunglasses

Regulatory & Marketing

Labeler Name
Gnl Brands International, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-30-2024
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 85638-003-37 identifies a specific commercial package of 156 g in 1 can of Ocean Potion Suncare 30 Continuous Sunscreen Scent Of Sunshine, a human over the counter drug labeled by Gnl Brands International, Llc. This spray 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 Gnl Brands International, Llc on August 30, 2024. The current certification is valid through December 31, 2026.

How is this Gnl Brands International, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85638000337. 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)
85638-003-37
11-Digit CMS (5-4-2)
85638-0003-37

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