Spf30 Sunscreen And Spf15 Kit
NDC Package 70412-818-01

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

Package Information

Spf30 Sunscreen And Spf15 (avobenzone, homosalate, octocrylene, octisalate) kits is non-Water Resistant Product • Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: Ask a doctor Sun Protection Measures. This formulation utilizes a kit delivery system. Marketed by Zhejiang Ayan Biotech Co.,ltd., this product is identified by NDC 70412-818 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
70412-818-01
Package Description
1 KIT in 1 KIT * 30 mL in 1 BOTTLE (70412-231-30) * 2 g in 1 TUBE (70412-316-07)
Product Code
70412-818
11-Digit Billing Format
70412081801

Clinical Specifications

Proprietary Name
Spf30 Sunscreen And Spf15
Non-Proprietary Name
Avobenzone, Homosalate, Octocrylene, Octisalate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Non-Water Resistant Product • Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: Ask a doctor 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. to 2 p.m. • Wear long sleeve shirts, pants, hats and sunglasses. Non-Water Resistant ProductApply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingReapply at least every 2 hoursChildren 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: •Limit time in the sun, especially from 10 a.m. to 2 p.m. •Wear long sleeve shirts, pants, hats and sunglasses. Apply liberally 15 minutes before sun exposure.Usa a water resistant sunscreen if swimming or sweating.Reapply at least every 2 hours.Children under 6 months: Ask a doctor.

Regulatory & Marketing

Labeler Name
Zhejiang Ayan Biotech Co.,ltd.
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-01-2018
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 70412-818-01 identifies a specific commercial package of 1 kit in 1 kit * 30 ml in 1 bottle (70412-231-30) * 2 g in 1 tube (70412-316-07) of Spf30 Sunscreen And Spf15, a human over the counter drug labeled by Zhejiang Ayan Biotech Co.,ltd.. This kit is formulated for use and contains 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 Zhejiang Ayan Biotech Co.,ltd. on December 01, 2018. The current certification is valid through December 31, 2026.

How is this Zhejiang Ayan Biotech Co.,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70412081801. 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)
70412-818-01
11-Digit CMS (5-4-2)
70412-0818-01

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