Broad Spectrum Spf 30 Up The Anti Cream
NDC Package 42485-005-01

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

Package Information

Broad Spectrum Spf 30 Up The Anti (titanium dioxide, zinc oxide) cream is apply to face and under throat after cleansingreapply:after excessive perspirationSun Protection Measures. This formulation utilizes a cream delivery system. Marketed by Biopelle, Inc., this product is identified by NDC 42485-005 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
42485-005-01
Package Description
75 mL in 1 BOTTLE
Product Code
42485-005
11-Digit Billing Format
42485000501

Clinical Specifications

Proprietary Name
Broad Spectrum Spf 30 Up The Anti
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 to face and under throat after cleansingreapply:after excessive perspirationSun 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 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.  - 2 p.m.wear long sleeve shirts, pants, hats and sunglasseschildren under 6 months: Ask a doctor

Regulatory & Marketing

Labeler Name
Biopelle, Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-14-2012
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 42485-005-01 identifies a specific commercial package of 75 ml in 1 bottle of Broad Spectrum Spf 30 Up The Anti, a human over the counter drug labeled by Biopelle, 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 Biopelle, Inc. on November 14, 2012. The current certification is valid through December 31, 2026.

How is this Biopelle, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42485000501. 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)
42485-005-01
11-Digit CMS (5-4-2)
42485-0005-01

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