Hawaiian Tropic Oil
NDC Package 63354-784-16

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

Package Information

Hawaiian Tropic (avobenzone, octisalate, octocrylene) oils is • apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two hours • Sun Protection Measures. This formulation utilizes a oil delivery system. Marketed by Edgewell Personal Care Brands Llc, this product is identified by NDC 63354-784 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
63354-784-16
Package Description
236 g in 1 BOTTLE, PUMP
Product Code
63354-784
11-Digit Billing Format
63354078416

Clinical Specifications

Proprietary Name
Hawaiian Tropic
Non-Proprietary Name
Avobenzone, Octisalate, Octocrylene
Substance Name
Avobenzone; Octisalate; Octocrylene
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
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 • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two hours • Sun Protection Measures. Spending time in the sun with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Regulatory & Marketing

Labeler Name
Edgewell Personal Care Brands Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-02-2025
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 63354-784-16 identifies a specific commercial package of 236 g in 1 bottle, pump of Hawaiian Tropic, a human over the counter drug labeled by Edgewell Personal Care Brands Llc. This oil is formulated for topical use and contains avobenzone; 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 Edgewell Personal Care Brands Llc on April 02, 2025. The current certification is valid through December 31, 2026.

How is this Edgewell Personal Care Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63354078416. 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)
63354-784-16
11-Digit CMS (5-4-2)
63354-0784-16

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