Os-01 Lip Spf 15 Bare Blush Cream
NDC Package 84451-007-02

11-digit billing NDC: 84451000702
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Os-01 Lip Spf 15 Bare Blush (zinc oxide) cream is uses • Helps prevent sunburn. This formulation utilizes a cream delivery system. Marketed by Oneskin, this product is identified by NDC 84451-007 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
84451-007-02
Package Description
1 TUBE in 1 CARTON / 12 g in 1 TUBE (84451-007-01)
Product Code
84451-007
11-Digit Billing Format
84451000702

Clinical Specifications

Proprietary Name
Os-01 Lip Spf 15 Bare Blush
Non-Proprietary Name
Zinc Oxide
Substance Name
Zinc Oxide
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
ZINC OXIDE 5.5 g/100g
Usage Information
Uses • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions). decreases the risk of skin cancer and early skin aging caused by the sun.

Regulatory & Marketing

Labeler Name
Oneskin
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-13-2026
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 84451-007-02 identifies a specific commercial package of 1 tube in 1 carton / 12 g in 1 tube (84451-007-01) of Os-01 Lip Spf 15 Bare Blush, a human over the counter drug labeled by Oneskin. This cream is formulated for topical use and contains 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 Oneskin on October 13, 2026. The current certification is valid through December 31, 2027.

How is this Oneskin product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84451000702. 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)
84451-007-02
11-Digit CMS (5-4-2)
84451-0007-02

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