Dr. C Tuna Sunscreen 30 Spf Broad Spectrum Face And Body Cream
NDC Package 78317-000-01

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

Package Information

Dr. C Tuna Sunscreen 30 Spf Broad Spectrum Face And Body (avobenzone, octinoxate, octocrylene, homosalate) cream is for suncreen use:-Applygenerously 15 minutes before sun exposure. This formulation utilizes a cream delivery system. Marketed by Tan-alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret Anonim Sirketi, this product is identified by NDC 78317-000 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
78317-000-01
Package Description
1 TUBE in 1 BOX / 75 mL in 1 TUBE
Product Code
78317-000
11-Digit Billing Format
78317000001

Clinical Specifications

Proprietary Name
Dr. C Tuna Sunscreen 30 Spf Broad Spectrum Face And Body
Non-Proprietary Name
Avobenzone, Octinoxate, Octocrylene, Homosalate
Substance Name
Avobenzone; Homosalate; Octinoxate; Octocrylene
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
For suncreen use:-Applygenerously 15 minutes before sun exposure. - Reapply; - after 80 minutes of swimming or sweating - immediately  after towel drying  - at least  every 2 hours Sun Protection Measures; Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regular use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including; - limit in the sun, especially from 10 a.m -2 p.m. - wear long - sleeved shirts, pants, hats and sun glasses - children under 6 months of age: Ask a doctor

Regulatory & Marketing

Labeler Name
Tan-alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret Anonim Sirketi
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2020
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 78317-000-01 identifies a specific commercial package of 1 tube in 1 box / 75 ml in 1 tube of Dr. C Tuna Sunscreen 30 Spf Broad Spectrum Face And Body, a human over the counter drug labeled by Tan-alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret Anonim Sirketi. This cream is formulated for topical use and contains avobenzone; homosalate; octinoxate; octocrylene 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 Tan-alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret Anonim Sirketi on June 01, 2020. The current certification is valid through December 31, 2026.

How is this Tan-alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret Anonim Sirketi product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78317000001. 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)
78317-000-01
11-Digit CMS (5-4-2)
78317-0000-01

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