Sheer Tint Mineral Sunscreen Broad Spectrum Spf 50 - Medium/deep Shade Lotion
NDC Package 51514-0362-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Sheer Tint Mineral Sunscreen Broad Spectrum Spf 50 - Medium/deep Shade (spf 50 sunscreen broad spectrum - medium/deep shade) lotions is apply generously 15 minutes before sun exposureReapply every 2 hoursUse a water resistant sunscreen if swimming or sweatingSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. This formulation utilizes a lotion delivery system. Marketed by Autumn Harp, this product is identified by NDC 51514-0362 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
51514-0362-1
Package Description
46 g in 1 BOTTLE
Product Code
11-Digit Billing Format
51514036201

Clinical Specifications

Proprietary Name
Sheer Tint Mineral Sunscreen Broad Spectrum Spf 50 - Medium/deep Shade
Non-Proprietary Name
Spf 50 Sunscreen Broad Spectrum - Medium/deep Shade
Substance Name
Titanium Dioxide; Zinc Oxide
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.
Usage Information
Apply generously 15 minutes before sun exposureReapply every 2 hoursUse a water resistant sunscreen if swimming or sweatingSun 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 10am - 2pm,Wear long-sleeved shirts, pants, hats, and sunglassesChildren under 6 months of age: Ask a doctor

Regulatory & Marketing

Labeler Name
Autumn Harp
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

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 51514-0362-1 identifies a specific commercial package of 46 g in 1 bottle of Sheer Tint Mineral Sunscreen Broad Spectrum Spf 50 - Medium/deep Shade, a human over the counter drug labeled by Autumn Harp. This lotion 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 Autumn Harp on July 15, 2023. The current certification is valid through December 31, 2026.

How is this Autumn Harp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51514036201. 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)
51514-0362-1
11-Digit CMS (5-4-2)
51514-0362-01

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