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  5. NDC Package Code: 43419-416-31 Iope Perfect Cover Cushion 21

NDC Package 43419-416-31 Iope Perfect Cover Cushion 21

Octinoxate,Titanium Dioxide,And Zinc Oxide Lotion Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
43419-416-31
Package Description:
2 CONTAINER in 1 CARTON / 15 g in 1 CONTAINER
Product Code:
43419-416
Proprietary Name:
Iope Perfect Cover Cushion 21
Non-Proprietary Name:
Octinoxate, Titanium Dioxide, And Zinc Oxide
Substance Name:
Octinoxate; Titanium Dioxide; Zinc Oxide
Usage Information:
Apply liberally 15 minutes before sun exposureChildren under 6 months of age : Ask a doctor.Reapply at least every 2 hours.Use a water-resistant sunscreen if swimming or sweating.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.
11-Digit NDC Billing Format:
43419041631
Product Type:
Human Otc Drug
Labeler Name:
Amorepacific Corporation
Dosage Form:
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Administration Route(s):
  • 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):
  • OCTINOXATE 1.797 mg/30g
  • TITANIUM DIOXIDE .996 mg/30g
  • ZINC OXIDE 1.764 mg/30g
    • Sample Package:
    No
    FDA Application Number:
    M020
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    02-01-2020
    End Marketing Date:
    10-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 43419-416-31?

    The NDC Packaged Code 43419-416-31 is assigned to a package of 2 container in 1 carton / 15 g in 1 container of Iope Perfect Cover Cushion 21, a human over the counter drug labeled by Amorepacific Corporation. The product's dosage form is lotion and is administered via topical form.

    Is NDC 43419-416 included in the NDC Directory?

    Yes, Iope Perfect Cover Cushion 21 with product code 43419-416 is active and included in the NDC Directory. The product was first marketed by Amorepacific Corporation on February 01, 2020.

    What is the 11-digit format for NDC 43419-416-31?

    The 11-digit format is 43419041631. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-243419-416-315-4-243419-0416-31