Banana Boat Baby Mineral Enriched Sunscreen Uva/uvb Protection Broad Spectrum Spf 50plus Lotion
NDC Package 63354-682-13

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

Package Information

Banana Boat Baby Mineral Enriched Sunscreen Uva/uvb Protection Broad Spectrum Spf 50plus (homosalate, octisalate, octocrylene, zinc oxide) lotions is shake well. This formulation utilizes a lotion delivery system. Marketed by Edgewell Personal Care Brands Llc, this product is identified by NDC 63354-682 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
63354-682-13
Package Description
147 g in 1 BOTTLE, PLASTIC
Product Code
63354-682
11-Digit Billing Format
63354068213

Clinical Specifications

Proprietary Name
Banana Boat Baby Mineral Enriched Sunscreen Uva/uvb Protection Broad Spectrum Spf 50plus
Non-Proprietary Name
Homosalate, Octisalate, Octocrylene, Zinc Oxide
Substance Name
Homosalate; Octisalate; Octocrylene; Zinc Oxide
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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. Hold container 4 to 6 inches from the skin to apply. Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands and then apply to face • Do not apply in windy conditions • Use in a well-ventilated area • Reapply: • after 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children 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 a.m.–2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses

Regulatory & Marketing

Labeler Name
Edgewell Personal Care Brands Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2021
End Marketing Date
10-01-2027
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 63354-682-13 identifies a specific commercial package of 147 g in 1 bottle, plastic of Banana Boat Baby Mineral Enriched Sunscreen Uva/uvb Protection Broad Spectrum Spf 50plus, a human over the counter drug labeled by Edgewell Personal Care Brands Llc. This lotion is formulated for topical use and contains homosalate; octisalate; octocrylene; zinc oxide 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 Edgewell Personal Care Brands Llc on October 01, 2021.

How is this Edgewell Personal Care Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63354068213. 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)
63354-682-13
11-Digit CMS (5-4-2)
63354-0682-13

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