Silk Line Silk Day Cream Spf 15 Cream
NDC Package 53863-003-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Silk Line Silk Day Cream Spf 15 (octinoxate, octocrylene, octisalate) cream is stop use and ask a doctor if rash occurs. This formulation utilizes a cream delivery system. Marketed by Exelencia Importers, Corp., this product is identified by NDC 53863-003 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
53863-003-01
Package Description
50 mL in 1 BOX
Product Code
11-Digit Billing Format
53863000301

Clinical Specifications

Proprietary Name
Silk Line Silk Day Cream Spf 15
Non-Proprietary Name
Octinoxate, Octocrylene, Octisalate
Substance Name
Octinoxate; Octisalate; Octocrylene
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.
Usage Information
Stop use and ask a doctor if rash occurs

Regulatory & Marketing

Labeler Name
Exelencia Importers, Corp.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-26-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

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 53863-003-01 identifies a specific commercial package of 50 ml in 1 box of Silk Line Silk Day Cream Spf 15, a human over the counter drug labeled by Exelencia Importers, Corp.. This cream is formulated for topical use and contains octinoxate; octisalate; octocrylene 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 Exelencia Importers, Corp. on October 26, 2020. The current certification is valid through December 31, 2026.

How is this Exelencia Importers, Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53863000301. 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)
53863-003-01
11-Digit CMS (5-4-2)
53863-0003-01

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