Protect And Prime Broad Spectrum Spf30 Cream
NDC Package 70453-001-01

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

Package Information

Protect And Prime Broad Spectrum Spf30 (avobenzone, octinoxate, octocrylene, oxybenzone) cream is apply generously 15 minutes before sun exposureUse a Water Resistant sunscreen if swimming or sweatingReapply at least every 2 hoursSun Protection Measures. This formulation utilizes a cream delivery system. Marketed by Emma Hardie Ltd, this product is identified by NDC 70453-001 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
70453-001-01
Package Description
1 BOTTLE in 1 BOX / 50 mL in 1 BOTTLE
Product Code
70453-001
11-Digit Billing Format
70453000101

Clinical Specifications

Proprietary Name
Protect And Prime Broad Spectrum Spf30
Non-Proprietary Name
Avobenzone, Octinoxate, Octocrylene, Oxybenzone
Substance Name
Avobenzone; Octinoxate; Octocrylene; Oxybenzone
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)
Usage Information
Apply generously 15 minutes before sun exposureUse a Water Resistant sunscreen if swimming or sweatingReapply at least every 2 hoursSun 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
Emma Hardie Ltd
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-03-2016
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 70453-001-01 identifies a specific commercial package of 1 bottle in 1 box / 50 ml in 1 bottle of Protect And Prime Broad Spectrum Spf30, a human over the counter drug labeled by Emma Hardie Ltd. This cream is formulated for topical use and contains avobenzone; octinoxate; octocrylene; oxybenzone 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 Emma Hardie Ltd on February 03, 2016. The current certification is valid through December 31, 2026.

How is this Emma Hardie Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70453000101. 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)
70453-001-01
11-Digit CMS (5-4-2)
70453-0001-01

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