Home NDC 84425-101 Standard Procedure SPF 50 Sunscreen
Product NDC 84425-101
11-digit product format 844250101
Labeler code 84425
Product ID 84425-101_4862fbef-e8ad-cc4b-e063-6394a90a35f2
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octocrylene, Octisalate, Avobenzone
Dosage form LOTION
Route TOPICAL
Labeler Standard Procedure Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-15
Substance OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength 80; 30; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Standard Procedure SPF 50 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 80 mg/mL AVOBENZONE 30 mg/mL HOMOSALATE 100 mg/mL OCTISALATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84425-101-01 Standard Procedure SPF 50 Sunscreen 60 mL in 1 BOTTLE, PLASTIC LOTION 60 2 84425-101-03 Standard Procedure SPF 50 Sunscreen 250 mL in 1 BOTTLE, PLASTIC LOTION 250 2 84425-101-04 Standard Procedure SPF 50 Sunscreen 500 mL in 1 BOTTLE, PLASTIC LOTION 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84425-101 STANDARD PROCEDURE SPF 50 SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [STANDARD PROCEDURE INC] 1 Current NDC, 3 package rows 20240821_1d3f87de-90c0-75c0-e063-6394a90a2ef4.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 131 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Scottsdale Skin Boutique and Dermatology Pllc 34a52011-b781-75cf-e063-6394a90ae0f4 2025-12-11 Exact identifier application number: M020 Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Scottsdale Skin Boutique and Dermatology Pllc 34a632f5-4458-e335-e063-6394a90a9bcb 2025-12-11 Exact identifier application number: M020 D FEND DAILY ZINC OXIDE CLEAN BEAUTY BY ANAK LLC 3762dc16-055e-43fd-e063-6394a90ad3c8 2025-12-11 Exact identifier application number: M020 Tinted Sunscreen ZINC OXIDE Scottsdale Skin Boutique and Dermatology Pllc 34a66140-0d36-005a-e063-6394a90a2a0b 2025-12-11 Exact identifier application number: M020 Instant Glow ZINC OXIDE CLEAN BEAUTY BY ANAK LLC 37634726-fb70-f209-e063-6294a90a5d3b 2025-12-11 Exact identifier application number: M020 Matte Finish TITANIUM DIOXIDE, ZINC OXIDE CLEAN BEAUTY BY ANAK LLC 3761d74c-0137-0c75-e063-6394a90a3c7d 2025-12-11 Exact identifier application number: M020 Sun Plus Sun Lip Shield TITANIUM DIOXIDE, ZINC OXIDE CLEAN BEAUTY BY ANAK LLC 3763a79a-e881-cade-e063-6394a90a49de 2025-12-11 Exact identifier application number: M020 Tinted Minerals 1point8 oz TITANIUM DIOXIDE, ZINC OXIDE SPECKTRA6 LLC 374e53c6-307f-f8e5-e063-6394a90a07ef 2025-12-11 Exact identifier application number: M020 Tinted Minerals 1point8 oz TITANIUM DIOXIDE, ZINC OXIDE SPECKTRA6 LLC 373e29f1-d665-a3c4-e063-6294a90a403e 2025-12-11 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE SPECKTRA6 LLC 374e1c8e-5c5c-9198-e063-6294a90a3b88 2025-12-11 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE SPECKTRA6 LLC 374f063a-1ea6-2fcc-e063-6394a90ac574 2025-12-11 Exact identifier application number: M020 Defend Tinted Mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE SMOOTH ESTHETICS LLC 36eb9fc0-25d7-cfb4-e063-6394a90a2e22 2025-12-11 Exact identifier application number: M020 Sheer Tinted Sunscreen SPF40 TITANIUM DIOXIDE, ZINC OXIDE SIMPLICITY SKIN, SPA & BOUTIQUE, LLC 36ebdb85-ce8a-d7e0-e063-6394a90a2261 2025-12-11 Exact identifier application number: M020 Solar Shield Face and Body SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b138432-19e5-e757-e063-6294a90a4cbe 2025-12-11 Warnings Exact identifier application number: M020 Solar Shield Primer SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b149758-bbe1-bd66-e063-6294a90afe78 2025-12-11 Warnings Exact identifier application number: M020 Solar Shield Face and Body SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b14caa3-f58e-b9ab-e063-6394a90a9695 2025-12-11 Warnings Exact identifier application number: M020 Solar Shield Primer SPF 40 ZINC OXIDE BRIGHT SKINCARE, LLC 3b152e27-3917-eb7e-e063-6394a90a1f43 2025-12-11 Warnings Exact identifier application number: M020 Mineral Lip Protection TITANIUM DIOXIDE, ZINC OXIDE COLETTE TOMASI LLC 3727b29f-fe51-0b15-e063-6394a90a780b 2025-12-11 Exact identifier application number: M020 Daytime Moisture SPF40 ZINC OXIDE COLETTE TOMASI LLC 372773b6-fc37-c74b-e063-6294a90a7bf2 2025-12-11 Exact identifier application number: M020 Prevention Acne Safe Facial Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE NY BEAUTY PALACE LLC 373c291a-7839-8486-e063-6294a90a5af3 2025-12-11 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84425-101-01 84425010101 60 mL in 1 BOTTLE, PLASTIC (84425-101-01) 60 ml 2024-07-15 No No Current 84425-101-03 84425010103 250 mL in 1 BOTTLE, PLASTIC (84425-101-03) 250 ml 2024-07-15 No No Current 84425-101-04 84425010104 500 mL in 1 BOTTLE, PLASTIC (84425-101-04) 500 ml 2024-07-15 No No Current