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  5. NDC Package Code: 80971-102-01 Protect Prevent Daily Mineral Sunscreen Broad Spectrum Spf30

NDC Package 80971-102-01 Protect Prevent Daily Mineral Sunscreen Broad Spectrum Spf30

Titanium Dioxide,Zinc Oxide Cream 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:
80971-102-01
Package Description:
1 TUBE in 1 CARTON / 50 mL in 1 TUBE
Product Code:
80971-102
Proprietary Name:
Protect Prevent Daily Mineral Sunscreen Broad Spectrum Spf30
Non-Proprietary Name:
Titanium Dioxide, Zinc Oxide
Substance Name:
Titanium Dioxide; Zinc Oxide
Usage Information:
Apply liberally 15 minutes before sun exposure.Reapply at least every 2 hours.Reapply after 40 minutes of swimming or sweating.Reapply immediately after towel drying.Children under 6 months of age: 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 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.; and wear long-sleeved shirts, pants, hats and sunglasses. Store in a cool dry place.Do not use if safety seal is broken.May stain some fabric.Protect the product in this container from excessive heat and direct sun.
11-Digit NDC Billing Format:
80971010201
Product Type:
Human Otc Drug
Labeler Name:
Norwex Usa, Inc.
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(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):
  • TITANIUM DIOXIDE 28.8 mg/mL
  • ZINC OXIDE 68 mg/mL
    • Pharmacologic Class(es):
  • Copper Absorption Inhibitor - [EPC] (Established Pharmacologic Class)
  • Decreased Copper Ion Absorption - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    part352
    Marketing Category:
    OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
    Start Marketing Date:
    01-01-2023
    Listing Expiration Date:
    12-31-2024
    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 80971-102-01?

    The NDC Packaged Code 80971-102-01 is assigned to a package of 1 tube in 1 carton / 50 ml in 1 tube of Protect Prevent Daily Mineral Sunscreen Broad Spectrum Spf30, a human over the counter drug labeled by Norwex Usa, Inc.. The product's dosage form is cream and is administered via topical form.

    Is NDC 80971-102 included in the NDC Directory?

    Yes, Protect Prevent Daily Mineral Sunscreen Broad Spectrum Spf30 with product code 80971-102 is active and included in the NDC Directory. The product was first marketed by Norwex Usa, Inc. on January 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 80971-102-01?

    The 11-digit format is 80971010201. 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
    5-3-280971-102-015-4-280971-0102-01