Nena Mineral Sunscreen Spf 30 Cream
NDC Package 52311-686-01

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Nena Mineral Sunscreen Spf 30 (titanium dioxide, zinc oxide) cream is apply liberally and evenly 15 minutes before sun exposure. This formulation utilizes a cream delivery system. Marketed by Ironwood Clay Company Inc., this product is identified by NDC 52311-686 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
52311-686-01
Package Description
1 TUBE in 1 BOX / 50 mL in 1 TUBE
Product Code
52311-686
11-Digit Billing Format
52311068601

Clinical Specifications

Proprietary Name
Nena Mineral Sunscreen Spf 30
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; 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)
Usage Information
Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months of age: 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. Use a water resistant sunscreen if swimming or sweating.

Regulatory & Marketing

Labeler Name
Ironwood Clay Company Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-17-2024
End Marketing Date
06-30-2026
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 52311-686-01 identifies a specific commercial package of 1 tube in 1 box / 50 ml in 1 tube of Nena Mineral Sunscreen Spf 30, a human over the counter drug labeled by Ironwood Clay Company Inc.. This cream 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 Ironwood Clay Company Inc. on June 17, 2024.

How is this Ironwood Clay Company Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52311068601. 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)
52311-686-01
11-Digit CMS (5-4-2)
52311-0686-01

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