Intellishade Original Spf 45 Cream
NDC Package 64651-7749-2

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

Package Information

Intellishade Original Spf 45 (octinoxate, octisalate, titanium dioxide, zinc oxide) cream is uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun. This formulation utilizes a cream delivery system. Marketed by Revision, Llc, this product is identified by NDC 64651-7749 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
64651-7749-2
Package Description
227 g in 1 TUBE
Product Code
64651-7749
11-Digit Billing Format
64651774902

Clinical Specifications

Proprietary Name
Intellishade Original Spf 45
Non-Proprietary Name
Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide
Substance Name
Octinoxate; Octisalate; 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
Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Regulatory & Marketing

Labeler Name
Revision, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-09-2013
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (64651-7749). Click a package code to view its specific billing and regulatory data.

64651-7749-1
1 TUBE in 1 CARTON / 48 g in 1 TUBE
64651-7749-3
3 g in 1 TUBE

* 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 64651-7749-2 identifies a specific commercial package of 227 g in 1 tube of Intellishade Original Spf 45, a human over the counter drug labeled by Revision, Llc. This cream is formulated for topical use and contains octinoxate; octisalate; 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 Revision, Llc on July 09, 2013. The current certification is valid through December 31, 2027.

How is this Revision, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64651774902. 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 (5-4-1)
64651-7749-2
11-Digit CMS (5-4-2)
64651-7749-02

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