Home NDC 84425-101-01 Standard Procedure SPF 50 Sunscreen
Product NDC 84425-101
Requested package NDC 84425-101-01
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 119 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Physical Defense TITANIUM DIOXIDE, ZINC OXIDE ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER 35477ed2-0875-58d5-e063-6294a90a3d5d 2025-12-15 Exact identifier application number: M020 Anti Aging Daily Protection ZINC OXIDE LEVERRIER, KAMILA 35465f21-8bcd-6e44-e063-6294a90a8e5f 2025-12-15 Exact identifier application number: M020 Anti Aging Daily Protection ZINC OXIDE LEVERRIER, KAMILA 3546d369-3435-b56a-e063-6294a90a0843 2025-12-15 Exact identifier application number: M020 Tinted Facial Sunscreen TITANIUM DIOXIDE, ZINC OXIDE HELTON SKIN & LASER INSTITUTE 35a97770-2db9-99aa-e063-6294a90a459a 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE HELTON SKIN & LASER INSTITUTE 35a9d07d-70e5-5eed-e063-6394a90aebaf 2025-12-15 Exact identifier application number: M020 Non-Tinted Sports Stick TITANIUM DIOXIDE, ZINC OXIDE HELTON SKIN & LASER INSTITUTE 35aa833a-19a1-99e9-e063-6394a90a840f 2025-12-15 Exact identifier application number: M020 Tinted Facial Primer TITANIUM DIOXIDE, ZINC OXIDE BEE NATURALS 36c3352e-fa51-19ad-e063-6394a90a591b 2025-12-15 Exact identifier application number: M020 Luminous Tinted Moisturizing ZINC OXIDE SKIN BOSS L.L.C. 35a8ae26-82eb-e4ca-e063-6394a90a0022 2025-12-15 Exact identifier application number: M020 Restore Tinted Moisturizing ZINC OXIDE SKIN BOSS L.L.C. 35a8e92e-ced2-fdcd-e063-6294a90acedc 2025-12-15 Exact identifier application number: M020 Velvet Tinted Moisturizing Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SKIN BOSS L.L.C. 35a871dc-a707-9963-e063-6294a90a4396 2025-12-15 Exact identifier application number: M020 Velvet NT Moisturizing Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SKIN BOSS L.L.C. 35a8508d-7069-c2d6-e063-6394a90a6219 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen NT ZINC OXIDE SKINPLUSBYOROYO LLC 35a94d6f-9b1c-1b26-e063-6394a90abe65 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen NT ZINC OXIDE SKINPLUSBYOROYO LLC 35a9a6ed-c446-c90c-e063-6294a90aaa74 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen Tinted ZINC OXIDE SKINPLUSBYOROYO LLC 35a9ecd7-b416-0aab-e063-6294a90a323d 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer NT TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 3596fe93-836b-4f8e-e063-6294a90a674a 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 359723bb-6152-9566-e063-6294a90a59e0 2025-12-15 Exact identifier application number: M020 Daily Skin Protection Sunscreen Tinted ZINC OXIDE SKINPLUSBYOROYO LLC 35aa194a-9a2e-2b5f-e063-6294a90a9877 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer NT TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 3596cd73-0811-32bc-e063-6394a90ad132 2025-12-15 Exact identifier application number: M020 Proper Protection Plus Primer Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin & Proper LLC 359782d7-6601-7d96-e063-6394a90af9dc 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY RIKI LLC 37f1b692-0b80-0536-e063-6294a90ae863 2025-12-15 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