Cay Skin Isle Sheen Sunstick Spf 35 Stick
NDC Package 82657-007-01

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

Package Information

Cay Skin Isle Sheen Sunstick Spf 35 (avobenzone, homosalate, octisalate, octocrylene) sticks is apply liberally (generously) 15 minutes before sun exposureReapplyafter 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hourschildren under 6 months: ask a doctorSun Protection Measures. This formulation utilizes a stick delivery system. Marketed by Cay Skin, Inc., this product is identified by NDC 82657-007 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
82657-007-01
Package Description
1 CONTAINER in 1 CARTON / 15 g in 1 CONTAINER
Product Code
82657-007
11-Digit Billing Format
82657000701

Clinical Specifications

Proprietary Name
Cay Skin Isle Sheen Sunstick Spf 35
Non-Proprietary Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Substance Name
Avobenzone; Homosalate; Octisalate; Octocrylene
Dosage Form
Stick - A dosage form prepared in a relatively long and slender often cylindrical form.
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 (generously) 15 minutes before sun exposureReapplyafter 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hourschildren under 6 months: ask a doctorSun 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 am. - 2 pmwear long-sleeved shirts, pants, hats, and sunglasses

Regulatory & Marketing

Labeler Name
Cay Skin, Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-19-2024
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 82657-007-01 identifies a specific commercial package of 1 container in 1 carton / 15 g in 1 container of Cay Skin Isle Sheen Sunstick Spf 35, a human over the counter drug labeled by Cay Skin, Inc.. This stick is formulated for topical use and contains avobenzone; homosalate; octisalate; 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 Cay Skin, Inc. on July 19, 2024. The current certification is valid through December 31, 2026.

How is this Cay Skin, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82657000701. 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)
82657-007-01
11-Digit CMS (5-4-2)
82657-0007-01

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