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 114 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kind Restore Tinted Mineral Sunscreen ZINC OXIDE POLISH BEAUTY 3980d278-c0f4-2c59-e063-6394a90aac37 2025-12-16 Exact identifier application number: M020 Solar Eclipse Extreme Sunscreen ZINC OXIDE ULTRAVIOLET SKINCARE LLC 36bfa691-48c0-8033-e063-6294a90ad899 2025-12-16 Exact identifier application number: M020 Kind Restore Moisturizing Lip Balm TITANIUM DIOXIDE, ZINC OXIDE POLISH BEAUTY 39814e27-4f3f-5ee6-e063-6394a90a941b 2025-12-16 Exact identifier application number: M020 Yoali SPF 40 ZINC OXIDE YOALI STUDIO LLC 390b7f9c-bc04-80ec-e063-6294a90a4092 2025-12-16 Exact identifier application number: M020 Skin Defense Matte Tinted Sunscreen ZINC OXIDE Gentlehomme LLC 365eb727-3e7f-f1dd-e063-6394a90aa469 2025-12-16 Exact identifier application number: M020 Dr B Clinical Skin Care Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE NAIRA BABAIAN, M.D., P.A. 365da1f8-5250-7589-e063-6294a90a3e68 2025-12-16 Exact identifier application number: M020 Dr B Clinical Skin Care Non Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE NAIRA BABAIAN, M.D., P.A. 365d7564-3025-257b-e063-6294a90ad170 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE Gentlehomme LLC 365e7d8e-e3e0-4c08-e063-6294a90af415 2025-12-16 Exact identifier application number: M020 Daily Replenish mineral sunscreen ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 369896b1-f4b4-6201-e063-6394a90a5bca 2025-12-16 Exact identifier application number: M020 Zinc 20 mineral sunscreen face Plus body ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 36985373-22dd-2232-e063-6394a90a76fb 2025-12-16 Exact identifier application number: M020 Matte Defense Mineral Sunscreen non tinted TITANIUM DIOXIDE, ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698090a-1639-00f9-e063-6394a90a7dd1 2025-12-16 Exact identifier application number: M020 Daily Replenish mineral sunscreen ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698d309-b9bf-e197-e063-6294a90af5a1 2025-12-16 Exact identifier application number: M020 Zinc 20 mineral sunscreen face Plus body ZINC OXIDE PURE VITALITY SKIN AND BODY, INC 3698f29e-5d80-94af-e063-6394a90a0489 2025-12-16 Exact identifier application number: M020 Tinted Mineral Primer SPF 40 TITANIUM DIOXIDE, ZINC OXIDE JOSEPHINA RAMIREZ 365cf2be-8862-3622-e063-6394a90ac4e3 2025-12-16 Exact identifier application number: M020 SANCTUARY Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CHAMPAGNE APOTHECARY LLC 365ca99c-c878-1f4b-e063-6394a90a1f53 2025-12-16 Exact identifier application number: M020 Tinted Mineral Defense SPF 40 ZINC OXIDE JOSEPHINA RAMIREZ 365d299a-5886-5597-e063-6394a90a336c 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILL VALLEY DERMATOLOGY, INC. 3b171a89-c757-47a1-e063-6294a90a7a64 2025-12-16 Warnings Exact identifier application number: M020 Tinted BB Cream ZINC OXIDE Eco Esthetics LLC 38f3e618-59e1-4504-e063-6394a90afa55 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE MADRE TIERRA, INC. 3f697463-d3db-7b73-e063-6394a90ac222 2025-12-16 Warnings Exact identifier application number: M020 Non-Tinted Replenishing Daily Protection ZINC OXIDE MADRE TIERRA, INC. 3f69d6f3-454b-e60a-e063-6394a90a8781 2025-12-16 Warnings 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