Cay Skin Isle Nourishing Body Mist Spf 50 Aerosol, Spray
NDC Package 82657-009-01

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 Nourishing Body Mist Spf 50 (avobenzone, octisalate, octocrylene) aerosols is apply liberally 15 minutes before sun exposure.Hold 4 to 6 inches away from body when spraying.Children under 6 months of age: Ask a doctor.Do not spray directly on face and avoid breathing mist.Spray on hand and apply to face. This formulation utilizes a aerosol, spray delivery system. Marketed by Cay Skin, Inc., this product is identified by NDC 82657-009 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
82657-009-01
Package Description
171 g in 1 CAN
Product Code
82657-009
11-Digit Billing Format
82657000901

Clinical Specifications

Proprietary Name
Cay Skin Isle Nourishing Body Mist Spf 50
Non-Proprietary Name
Avobenzone, Octisalate, Octocrylene
Substance Name
Avobenzone; Octisalate; Octocrylene
Dosage Form
Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.
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.Hold 4 to 6 inches away from body when spraying.Children under 6 months of age: Ask a doctor.Do not spray directly on face and avoid breathing mist.Spray on hand and apply to face. Use in well-ventilated areas.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 protections measures including:limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeved shirts, pants, hats and sunglasses.Reapply:after 80 minutes of running or sweating immediately after towel use or at least every two hours.

Regulatory & Marketing

Labeler Name
Cay Skin, Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 82657-009-01 identifies a specific commercial package of 171 g in 1 can of Cay Skin Isle Nourishing Body Mist Spf 50, a human over the counter drug labeled by Cay Skin, Inc.. This aerosol, spray is formulated for topical use and contains avobenzone; 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 June 01, 2023. 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: 82657000901. 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)
82657-009-01
11-Digit CMS (5-4-2)
82657-0009-01

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