Natrience Cream
NDC Package 84352-402-01

11-digit billing NDC: 84352040201
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Natrience (skin shield) cream is • Apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. This formulation utilizes a cream delivery system. Marketed by Sisel International, Llc, this product is identified by NDC 84352-402 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
84352-402-01
Package Description
1 TUBE in 1 BOX / 20 g in 1 TUBE
Product Code
84352-402
11-Digit Billing Format
84352040201

Clinical Specifications

Proprietary Name
Natrience Broad Spectrum Spf 30
Non-Proprietary Name
Skin Shield
Substance Name
Zinc Oxide
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)
ZINC OXIDE 20 g/100g
Usage Information
• Apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • 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 • For children under 6 months of age: Ask a doctor Apply a generous amount in an even layer to face and neck. Use daily as the last step in your skin care routine, before makeup, and at least 15 minutes before sun exposure.

Regulatory & Marketing

Labeler Name
Sisel International, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-15-2024
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 84352-402-01 identifies a specific commercial package of 1 tube in 1 box / 20 g in 1 tube of Natrience Broad Spectrum Spf 30, a human over the counter drug labeled by Sisel International, Llc. This cream is formulated for topical use and contains 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 Sisel International, Llc on June 15, 2024. The current certification is valid through December 31, 2026.

How is this Sisel International, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84352040201. 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)
84352-402-01
11-Digit CMS (5-4-2)
84352-0402-01

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