Refreshing Water Hydration Stick
NDC Package 79753-035-01

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

Package Information

Refreshing Water Hydration Stick (avobenzone octisalate homosalate octocrylene) sticks is useshelps prevent sunburnif used as directed with other sun protection measures   (see Directions), decreases the risk of skin cancer and  early skin aging caused by the sun. This formulation utilizes a stick delivery system. Marketed by Coola Llc, this product is identified by NDC 79753-035 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
79753-035-01
Package Description
1 CANISTER in 1 CARTON / 22 g in 1 CANISTER
Product Code
79753-035
11-Digit Billing Format
79753003501

Clinical Specifications

Proprietary Name
Refreshing Water Hydration Stick Spf 50
Non-Proprietary Name
Avobenzone Octisalate Homosalate 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
Useshelps prevent sunburnif used as directed with other sun protection measures   (see Directions), decreases the risk of skin cancer and  early skin aging caused by the sun

Regulatory & Marketing

Labeler Name
Coola Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-16-2023
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 79753-035-01 identifies a specific commercial package of 1 canister in 1 carton / 22 g in 1 canister of Refreshing Water Hydration Stick Spf 50, a human over the counter drug labeled by Coola Llc. 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 Coola Llc on January 16, 2023. The current certification is valid through December 31, 2026.

How is this Coola Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79753003501. 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)
79753-035-01
11-Digit CMS (5-4-2)
79753-0035-01

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