Coola Classic Body Spf 50 Guava Mango Spray
NDC Package 79753-059-01

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

Package Information

Coola Classic Body Spf 50 Guava Mango (avobenzone, homosalate, octisalate, octocrylene) sprays is shake WellApply liberally 15 minutes before sun exposure. This formulation utilizes a spray delivery system. Marketed by Coola, Llc, this product is identified by NDC 79753-059 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
79753-059-01
Package Description
177 mL in 1 CAN
Product Code
79753-059
11-Digit Billing Format
79753005901

Clinical Specifications

Proprietary Name
Coola Classic Body Spf 50 Guava Mango
Non-Proprietary Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Substance Name
Avobenzone; Homosalate; Octisalate; Octocrylene
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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 WellApply liberally 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply.Rub in. Do not spray directly on face.Spray onto hands and apply to face.Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours.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.​ Children under six months: Ask a doctor.

Regulatory & Marketing

Labeler Name
Coola, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (79753-059). Click a package code to view its specific billing and regulatory data.

79753-059-02
60 mL in 1 CAN

* 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 79753-059-01 identifies a specific commercial package of 177 ml in 1 can of Coola Classic Body Spf 50 Guava Mango, a human over the counter drug labeled by Coola, Llc. This spray 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 October 01, 2019. 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: 79753005901. 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)
79753-059-01
11-Digit CMS (5-4-2)
79753-0059-01

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