Tropicsurf Extreme Protection Spf30-ultra
NDC Package 70884-101-16

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tropicsurf Extreme Protection Spf30-ultra is aPPLY LIBERALLY 15 MINUTES PRIOR TO SUN EXPOSURE. Marketed by Palmer Surf Llc (dba X3embrands), this product is identified by NDC 70884-101 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
70884-101-16
Package Description
195 mL in 1 BOTTLE
Product Code
70884-101
11-Digit Billing Format
70884010116

Clinical Specifications

Proprietary Name
Tropicsurf Extreme Protection Spf30-ultra
Dosage Form
-
Usage Information
APPLY LIBERALLY 15 MINUTES PRIOR TO SUN EXPOSURE. REAPPLY AFTER80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWELDRYING; AND, AT LEAST EVERY 2 HOURS.SUN PROTECTION MEASURES:SPENDING TIME IN THE SUN INCREASES YOUR RISKI OF SKIN CANCER AND EARLY SKINAGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROADSPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURESINCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM TO 2 PM; WEARLONG-SLEEVE SHIRTS, PANTS, HATS AND SUNGLASSES; CHILDREN UNDER 6 MOS.OF AGE, ASK A DOCTOR

Regulatory & Marketing

Labeler Name
Palmer Surf Llc (dba X3embrands)
FDA Application #
part352
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
08-03-2016
Listing Expiration
12-31-2018
Exclude Flag
I
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 (70884-101). Click a package code to view its specific billing and regulatory data.

70884-101-03
90 mL in 1 BOTTLE
70884-101-11
45 mL in 1 BOTTLE
70884-101-13
390 mL in 1 BOTTLE
70884-101-32
960 mL in 1 BOTTLE

* 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 70884-101-16 identifies a specific commercial package of 195 ml in 1 bottle of Tropicsurf Extreme Protection Spf30-ultra, labeled by Palmer Surf Llc (dba X3embrands). This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Palmer Surf Llc (dba X3embrands) on August 03, 2016. The current certification is valid through December 31, 2018.

How is this Palmer Surf Llc (dba X3embrands) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70884010116. 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)
70884-101-16
11-Digit CMS (5-4-2)
70884-0101-16

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