Attitude
NDC Package 61649-003-75

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Attitude is - Apply liberally 15 minutes before sun exposure - Reapply: - At least every 2 hours - After 40 minutes of swimming or sweathing - Immediately after towel drying - 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 10am–2pm - Wear long-sleeved shirts, pants, hats, and sunglasses - Ask a doctor for use on children under 6 months of age. Marketed by Bio Spectra, this product is identified by NDC 61649-003 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
61649-003-75
Package Description
1 TUBE in 1 CARTON / 75 g in 1 TUBE
Product Code
61649-003
11-Digit Billing Format
61649000375

Clinical Specifications

Proprietary Name
Attitude Mineral Sunscreen Sensitive Skin Care Little Ones
Dosage Form
-
Usage Information
- Apply liberally 15 minutes before sun exposure - Reapply: - At least every 2 hours - After 40 minutes of swimming or sweathing - Immediately after towel drying - 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 10am–2pm - Wear long-sleeved shirts, pants, hats, and sunglasses - Ask a doctor for use on children under 6 months of age.

Regulatory & Marketing

Labeler Name
Bio Spectra
FDA Application #
part352
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
02-01-2017
Listing Expiration
12-31-2020
Exclude Flag
I
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 61649-003-75 identifies a specific commercial package of 1 tube in 1 carton / 75 g in 1 tube of Attitude Mineral Sunscreen Sensitive Skin Care Little Ones, labeled by Bio Spectra. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Bio Spectra on February 01, 2017. The current certification is valid through December 31, 2020.

How is this Bio Spectra product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61649000375. 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)
61649-003-75
11-Digit CMS (5-4-2)
61649-0003-75

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