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  5. NDC Package Code: 61354-047-04 Sunscreen

NDC Package 61354-047-04 Sunscreen

Homosalate,Octocrylene,Octisalate,Avobenzone Gel 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:
61354-047-04
Package Description:
1 CARTON in 1 PACKAGE / 1 PACKAGE in 1 CARTON (61354-047-03) / 1 TUBE in 1 PACKAGE (61354-047-02) / 100 mg in 1 TUBE (61354-047-01)
Product Code:
61354-047
Proprietary Name:
Sunscreen
Non-Proprietary Name:
Homosalate, Octocrylene, Octisalate, Avobenzone
Substance Name:
Avobenzone; Homosalate; Octisalate; Octocrylene
Usage Information:
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Reapply at least every 2 hours.Sun protection meassures: Spending time in the sun increasses 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, specially from 10 am - 2 pm, wear long-sleeved shirts, pants, hats and sunglasses.
11-Digit NDC Billing Format:
61354004704
Product Type:
Human Otc Drug
Labeler Name:
Oxygen Development, Llc
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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):
  • AVOBENZONE 3 mg/100mg
  • HOMOSALATE 10 mg/100mg
  • OCTISALATE 5 mg/100mg
  • OCTOCRYLENE 10 mg/100mg
    • Sample Package:
    No
    FDA Application Number:
    part352
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    02-14-2022
    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 61354-047-04?

    The NDC Packaged Code 61354-047-04 is assigned to a package of 1 carton in 1 package / 1 package in 1 carton (61354-047-03) / 1 tube in 1 package (61354-047-02) / 100 mg in 1 tube (61354-047-01) of Sunscreen, a human over the counter drug labeled by Oxygen Development, Llc. The product's dosage form is gel and is administered via topical form.

    Is NDC 61354-047 included in the NDC Directory?

    Yes, Sunscreen with product code 61354-047 is active and included in the NDC Directory. The product was first marketed by Oxygen Development, Llc on February 14, 2022 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 61354-047-04?

    The 11-digit format is 61354004704. 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
    5-3-261354-047-045-4-261354-0047-04