Back9ine Skincare Pure Invisible Sunscreen Spf 50 Gel
NDC Package 85536-585-00

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

Package Information

Back9ine Skincare Pure Invisible Sunscreen Spf 50 (avobenzone, homosalate, octisalate, octocrylene) gel is apply liberally 15 minutes before sun exposureChildren under 6 months of age: Ask a doctorReapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • do not spray directly on face. This formulation utilizes a gel delivery system. Marketed by Back 9ine Skincare, Llc, this product is identified by NDC 85536-585 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
85536-585-00
Package Description
1 BOTTLE, PUMP in 1 BOX / 50 mL in 1 BOTTLE, PUMP
Product Code
85536-585
11-Digit Billing Format
85536058500

Clinical Specifications

Proprietary Name
Back9ine Skincare Pure Invisible Sunscreen Spf 50
Non-Proprietary Name
Avobenzone, Homosalate, Octisalate, Octocrylene
Substance Name
Avobenzone; Homosalate; Octisalate; Octocrylene
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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 liberally 15 minutes before sun exposureChildren under 6 months of age: Ask a doctorReapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • do not spray directly on face. Spray into hands and apply to face • use in well ventilated areas 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

Regulatory & Marketing

Labeler Name
Back 9ine Skincare, Llc
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-31-2025
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 85536-585-00 identifies a specific commercial package of 1 bottle, pump in 1 box / 50 ml in 1 bottle, pump of Back9ine Skincare Pure Invisible Sunscreen Spf 50, a human over the counter drug labeled by Back 9ine Skincare, Llc. This gel 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 Back 9ine Skincare, Llc on January 31, 2025. The current certification is valid through December 31, 2026.

How is this Back 9ine Skincare, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85536058500. 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)
85536-585-00
11-Digit CMS (5-4-2)
85536-0585-00

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