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 26 of 357 · 7,139 matching rows.
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