Protective Tinted Moisturizer Broad Spectrum Sunscreen Spf 30 Paste
NDC Package 65278-104-01

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

Protective Tinted Moisturizer Broad Spectrum Sunscreen Spf 30 (titanium dioxide, zinc oxide) pastes 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. This formulation utilizes a paste delivery system. Marketed by June Jacobs Labs Llc, this product is identified by NDC 65278-104 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
65278-104-01
Package Description
50.28 g in 1 TUBE
Product Code
65278-104
11-Digit Billing Format
65278010401

Clinical Specifications

Proprietary Name
Protective Tinted Moisturizer Broad Spectrum Sunscreen Spf 30
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; Zinc Oxide
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty 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

Regulatory & Marketing

Labeler Name
June Jacobs Labs Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-08-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65278-104). Click a package code to view its specific billing and regulatory data.

65278-104-02
50.28 g in 1 CARTON

* 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 65278-104-01 identifies a specific commercial package of 50.28 g in 1 tube of Protective Tinted Moisturizer Broad Spectrum Sunscreen Spf 30, a human over the counter drug labeled by June Jacobs Labs Llc. This paste 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 June Jacobs Labs Llc on September 08, 2021. The current certification is valid through December 31, 2026.

How is this June Jacobs Labs Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65278010401. 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)
65278-104-01
11-Digit CMS (5-4-2)
65278-0104-01

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