Cetaphil Redness Relieving Daily Facial Moisturizer With Sunscreen Spf 40 Cream
NDC Package 0299-4138-00

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

Cetaphil Redness Relieving Daily Facial Moisturizer With Sunscreen Spf 40 (titanium dioxide, zinc oxide) cream is • Apply liberally 15 minutes before sun exposure.• Use a water resistant sunscreen if swimming or sweating• Reapply at least every 2 hours.• Children under 6 months: ask a doctorSUN PROTECTION MEASURES: Spending time in the sun increases your risk of cancer and early skin aging. This formulation utilizes a cream delivery system. Marketed by Galderma Laboratories, L.p., this product is identified by NDC 0299-4138 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
0299-4138-00
Package Description
1 TUBE in 1 CARTON / 50 mL in 1 TUBE
Product Code
0299-4138
11-Digit Billing Format
00299413800

Clinical Specifications

Proprietary Name
Cetaphil Redness Relieving Daily Facial Moisturizer With Sunscreen Spf 40
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 15 minutes before sun exposure.• Use a water resistant sunscreen if swimming or sweating• Reapply at least every 2 hours.• Children under 6 months: ask a doctorSUN PROTECTION MEASURES: Spending time in the sun increases your risk of 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 10am – 2 pm.• Wear long-sleeved shirts, pants, hats, and sun glasses.

Regulatory & Marketing

Labeler Name
Galderma Laboratories, L.p.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-20-2023
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 (0299-4138). Click a package code to view its specific billing and regulatory data.

0299-4138-05
10 mL 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 0299-4138-00 identifies a specific commercial package of 1 tube in 1 carton / 50 ml in 1 tube of Cetaphil Redness Relieving Daily Facial Moisturizer With Sunscreen Spf 40, a human over the counter drug labeled by Galderma Laboratories, L.p.. 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 Galderma Laboratories, L.p. on July 20, 2023. The current certification is valid through December 31, 2026.

How is this Galderma Laboratories, L.p. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00299413800. 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 (4-4-2)
0299-4138-00
11-Digit CMS (5-4-2)
00299-4138-00

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