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 118 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 39959db9-5ee1-a27c-e063-6394a90a1e10 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3995f556-20fe-3e64-e063-6294a90a5efe 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3995385b-b10b-ca5c-e063-6294a90af43f 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 3994aa84-30b4-3dc4-e063-6394a90a23e7 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE MILESTHETICS LLC 39947913-f1cc-25d2-e063-6294a90a4229 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE Micro Fibro Blast 35425e24-3e2c-51db-e063-6394a90a5580 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted ZINC OXIDE DENISE BELL SKIN CARE 396fe2ca-eb29-5952-e063-6294a90ab279 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f91b3-3326-3239-e063-6294a90a5df9 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE Micro Fibro Blast 35422370-eb55-049c-e063-6294a90ad0a4 2025-12-15 Exact identifier application number: M020 Eclipse Face Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f0151-2d0d-f4da-e063-6394a90a5f7f 2025-12-15 Exact identifier application number: M020 Eclipse Body Non Tinted ZINC OXIDE DENISE BELL SKIN CARE 396f56df-d0de-1344-e063-6294a90a46ea 2025-12-15 Exact identifier application number: M020 Solar Shield Tinted TITANIUM DIOXIDE, ZINC OXIDE DENISE BELL SKIN CARE 396eb781-5947-3665-e063-6294a90a38dd 2025-12-15 Exact identifier application number: M020 Sun Veil Illuminating Sunscreen SPF30 ZINC OXIDE Koco Life LLC 46001097-540e-65da-e063-6294a90af299 2025-12-15 Warnings Exact identifier application number: M020 Mineral Primer tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE Oracle Esthetics, LLC 3542d8d3-35a3-7d63-e063-6394a90a6fd1 2025-12-15 Exact identifier application number: M020 Mineral Primer non-tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE Oracle Esthetics, LLC 354357de-1a85-3bdb-e063-6294a90aa9a2 2025-12-15 Exact identifier application number: M020 Mineral Primer tinted SPF40 TITANIUM DIOXIDE, ZINC OXIDE Oracle Esthetics, LLC 35433254-1dc8-a8f3-e063-6394a90a29f0 2025-12-15 Exact identifier application number: M020 Sun Therapy Sunscreen ZINC OXIDE Skin Therapy Studio LLC 3544916b-3f63-3a7a-e063-6394a90ae507 2025-12-15 Exact identifier application number: M020 Ultra Zinc Mineral Non Tinted ZINC OXIDE Skin Therapy Studio LLC 3545d603-3d01-c51d-e063-6394a90a1599 2025-12-15 Exact identifier application number: M020 Sun Therapy Sunscreen ZINC OXIDE Skin Therapy Studio LLC 357efafb-aa1c-0d69-e063-6394a90a5135 2025-12-15 Exact identifier application number: M020 Ultra Zinc Mineral Non Tinted ZINC OXIDE Skin Therapy Studio LLC 35806102-6919-116f-e063-6294a90ad922 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 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