Topcare Everyday Mineral Sunscreen Continuous Broad Spectrum Spf 50 Reef-conscious Formula Spray
NDC Package 36800-284-50

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

Package Information

Topcare Everyday Mineral Sunscreen Continuous Broad Spectrum Spf 50 Reef-conscious Formula (titanium dioxide, zinc oxide) sprays is • spray liberally and spread evenly by hand 15 minutes before sun exposure • hold can 4-6 inches away from skin top apply • do not spray into face. This formulation utilizes a spray delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-284 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
36800-284-50
Package Description
179 g in 1 CAN
Product Code
36800-284
11-Digit Billing Format
36800028450

Clinical Specifications

Proprietary Name
Topcare Everyday Mineral Sunscreen Continuous Broad Spectrum Spf 50 Reef-conscious Formula
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; Zinc Oxide
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 skin top apply • do not spray into face. Spray into hand and apply to face. • use in a well ventilated areas reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: Ask a doctor • 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 sunglasses

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-17-2022
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 36800-284-50 identifies a specific commercial package of 179 g in 1 can of Topcare Everyday Mineral Sunscreen Continuous Broad Spectrum Spf 50 Reef-conscious Formula, a human over the counter drug labeled by Topco Associates Llc. This spray 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 Topco Associates Llc on January 17, 2022. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800028450. 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)
36800-284-50
11-Digit CMS (5-4-2)
36800-0284-50

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