Koa Protect Our Ocean Life Oxybenzone Free Broad Spectrum Spf 30 Uva Uvb Protection Sunscreen Cream
NDC Package 71889-350-08

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

Package Information

Koa Protect Our Ocean Life Oxybenzone Free Broad Spectrum Spf 30 Uva Uvb Protection Sunscreen (titanium dioxide, zinc oxide) cream is apply liberally 15-minutes before sun exposure. This formulation utilizes a cream delivery system. Marketed by Kapa'ihi, Inc, this product is identified by NDC 71889-350 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
71889-350-08
Package Description
1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE
Product Code
71889-350
11-Digit Billing Format
71889035008

Clinical Specifications

Proprietary Name
Koa Protect Our Ocean Life Oxybenzone Free Broad Spectrum Spf 30 Uva Uvb Protection Sunscreen
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; Zinc Oxide
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)
Pharmacologic Class
Usage Information
Apply liberally 15-minutes before sun exposure. Reapply at least every two-hours or immediately after swimming. sweating or towel drying. SUN PROTECTION MEASURES, Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician.

Regulatory & Marketing

Labeler Name
Kapa'ihi, Inc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-18-2017
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 71889-350-08 identifies a specific commercial package of 1 bottle in 1 carton / 236 ml in 1 bottle of Koa Protect Our Ocean Life Oxybenzone Free Broad Spectrum Spf 30 Uva Uvb Protection Sunscreen, a human over the counter drug labeled by Kapa'ihi, Inc. This cream is formulated for topical use and contains titanium dioxide; zinc oxide 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 Kapa'ihi, Inc on November 18, 2017. The current certification is valid through December 31, 2026.

How is this Kapa'ihi, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71889035008. 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)
71889-350-08
11-Digit CMS (5-4-2)
71889-0350-08

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