Bright Guard Sport Spf Lotion
NDC Package 76348-675-01

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

Package Information

Bright Guard Sport Spf (zinc spf) lotions is apply generously 15 minutes before sun exposureReapply after 80 minutes of swimming or sweating.reapply immediately after towel drying.Reapply 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 lotion delivery system. Marketed by Renu Laboratories, Llc, this product is identified by NDC 76348-675 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
76348-675-01
Package Description
1000 g in 1 POUCH
Product Code
76348-675
11-Digit Billing Format
76348067501

Clinical Specifications

Proprietary Name
Bright Guard Sport Spf
Non-Proprietary Name
Zinc Spf
Substance Name
Octinoxate; Octisalate; Titanium Dioxide; 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
Apply generously 15 minutes before sun exposureReapply after 80 minutes of swimming or sweating.reapply immediately after towel drying.Reapply 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including Limited time in the sun, especially between 10am and 2pm.Wear long sleeve shirts, pants, hats and sunglasses.For children under 6 months, consult a physician.

Regulatory & Marketing

Labeler Name
Renu Laboratories, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2021
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 76348-675-01 identifies a specific commercial package of 1000 g in 1 pouch of Bright Guard Sport Spf, a human over the counter drug labeled by Renu Laboratories, Llc. This lotion is formulated for topical use and contains octinoxate; octisalate; titanium dioxide; 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 Renu Laboratories, Llc on July 01, 2021. The current certification is valid through December 31, 2026.

How is this Renu Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76348067501. 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)
76348-675-01
11-Digit CMS (5-4-2)
76348-0675-01

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