Blue Lizard Sensitive Face Sunscreen Gel
NDC Package 0316-2056-17

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

Package Information

Blue Lizard Sensitive Face Sunscreen (titanium dioxide, zinc oxide) gel is shake well prior to useApply liberally to dry skin 15 minutes before sun exposureFor topical use only Keep out of reach of childrenChildren under 6 months: ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. This formulation utilizes a gel delivery system. Marketed by Crown Laboratories, this product is identified by NDC 0316-2056 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
0316-2056-17
Package Description
1 TUBE in 1 CARTON / 48 g in 1 TUBE
Product Code
0316-2056
11-Digit Billing Format
00316205617

Clinical Specifications

Proprietary Name
Blue Lizard Sensitive Face Sunscreen
Non-Proprietary Name
Titanium Dioxide, Zinc Oxide
Substance Name
Titanium Dioxide; Zinc Oxide
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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
Shake well prior to useApply liberally to dry skin 15 minutes before sun exposureFor topical use only Keep out of reach of childrenChildren under 6 months: ask a doctor 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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.Reapply to dry skin: At least every 2 hours Use a water resistant sunscreen if swimming or sweating

Regulatory & Marketing

Labeler Name
Crown Laboratories
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-30-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0316-2056-17 identifies a specific commercial package of 1 tube in 1 carton / 48 g in 1 tube of Blue Lizard Sensitive Face Sunscreen, a human over the counter drug labeled by Crown Laboratories. This gel 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 Crown Laboratories on January 30, 2019. The current certification is valid through December 31, 2027.

How is this Crown Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00316205617. 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)
0316-2056-17
11-Digit CMS (5-4-2)
00316-2056-17

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