My Medic Spf 30 Reef Friendly Sunscreen Cream
NDC Package 81417-009-01

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

Package Information

My Medic Spf 30 Reef Friendly Sunscreen (homosalate, titanium dioxide, ethylhexyl salicylate, phenylbenzimidazole sulfonic acid) cream is apply to skin liberally, avoiding the eye area.Wait at least 30 mins before sun exposure, or as directed by a physician.Re-apply after 80 mniutes of swimming and/or sweating.Re-apply immediately after towel drying and at least every 3 hours. This formulation utilizes a cream delivery system. Marketed by Sled Distribution, Llc, this product is identified by NDC 81417-009 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
81417-009-01
Package Description
3.5 g in 1 POUCH
Product Code
81417-009
11-Digit Billing Format
81417000901

Clinical Specifications

Proprietary Name
My Medic Spf 30 Reef Friendly Sunscreen
Non-Proprietary Name
Homosalate, Titanium Dioxide, Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid
Substance Name
Ensulizole; Homosalate; Octisalate; Titanium Dioxide
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)
Usage Information
Apply to skin liberally, avoiding the eye area.Wait at least 30 mins before sun exposure, or as directed by a physician.Re-apply after 80 mniutes of swimming and/or sweating.Re-apply immediately after towel drying and at least every 3 hours.

Regulatory & Marketing

Labeler Name
Sled Distribution, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-31-2022
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 81417-009-01 identifies a specific commercial package of 3.5 g in 1 pouch of My Medic Spf 30 Reef Friendly Sunscreen, a human over the counter drug labeled by Sled Distribution, Llc. This cream is formulated for topical use and contains ensulizole; homosalate; octisalate; titanium dioxide 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 Sled Distribution, Llc on October 31, 2022. The current certification is valid through December 31, 2026.

How is this Sled Distribution, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81417000901. 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)
81417-009-01
11-Digit CMS (5-4-2)
81417-0009-01

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