Babo Botanicals Super Shield Mineral Sunscreen Spf50 Aerosol, Spray
NDC Package 79265-7978-1

11-digit billing NDC: 79265797801
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Babo Botanicals Super Shield Mineral Sunscreen Spf50 (zinc oxide, titanium dioxide) aerosols is • shake well before use • hold container 4 to 6 inches from the skin to apply • apply liberally 15 minutes before sun exposure • do not spray directly into face • do not spray in windy condition • use in well-ventilated area • 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. This formulation utilizes a aerosol, spray delivery system. Marketed by Babo Botanicals, Inc., this product is identified by NDC 79265-7978 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
79265-7978-1
Package Description
177 mL in 1 CAN
Product Code
79265-7978
11-Digit Billing Format
79265797801

Clinical Specifications

Proprietary Name
Babo Botanicals Super Shield Mineral Sunscreen Spf50
Non-Proprietary Name
Zinc Oxide, Titanium Dioxide
Substance Name
Zinc Oxide; Titanium Dioxide
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
• shake well before use • hold container 4 to 6 inches from the skin to apply • apply liberally 15 minutes before sun exposure • do not spray directly into face • do not spray in windy condition • use in well-ventilated area • 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 of 15 or higher and other protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: ask a doctor

Regulatory & Marketing

Labeler Name
Babo Botanicals, Inc.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-30-2023
Listing Expiration
12-31-2027
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 79265-7978-1 identifies a specific commercial package of 177 ml in 1 can of Babo Botanicals Super Shield Mineral Sunscreen Spf50, a human over the counter drug labeled by Babo Botanicals, Inc.. This aerosol, spray is formulated for topical use and contains zinc oxide; titanium dioxide 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 Babo Botanicals, Inc. on October 30, 2023. The current certification is valid through December 31, 2027.

How is this Babo Botanicals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79265797801. 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)
79265-7978-1
11-Digit CMS (5-4-2)
79265-7978-01

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