Mineral Sunscreen Broad Spectrum Spf30 Lotion
NDC Package 53727-121-01

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

Package Information

Mineral Sunscreen Broad Spectrum Spf30 (titanium dioxide, zinc oxide) lotions is apply liberally and evenly 15 minutes before sun exposureReapply at least every 2 hoursUse a water-resistant sunscreen if swimming or sweatingImmediately after towel drying At least every 2 hoursChildren under 6 months of age: Ask a doctor Sun Protection Measures. This formulation utilizes a lotion delivery system. Marketed by Cosmecca Korea Co., Ltd, this product is identified by NDC 53727-121 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
53727-121-01
Package Description
50 g in 1 TUBE
Product Code
53727-121
11-Digit Billing Format
53727012101

Clinical Specifications

Proprietary Name
Mineral Sunscreen Broad Spectrum Spf30
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; Zinc Oxide
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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 and evenly 15 minutes before sun exposureReapply at least every 2 hoursUse a water-resistant sunscreen if swimming or sweatingImmediately after towel drying At least every 2 hoursChildren under 6 months of age: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of a 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.

Regulatory & Marketing

Labeler Name
Cosmecca Korea Co., Ltd
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-01-2023
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 53727-121-01 identifies a specific commercial package of 50 g in 1 tube of Mineral Sunscreen Broad Spectrum Spf30, a human over the counter drug labeled by Cosmecca Korea Co., Ltd. This lotion 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 Cosmecca Korea Co., Ltd on March 01, 2023. The current certification is valid through December 31, 2026.

How is this Cosmecca Korea Co., Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53727012101. 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)
53727-121-01
11-Digit CMS (5-4-2)
53727-0121-01

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