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 206 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Introstem Vitiscell Facial Shield OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 65c28ed6-649d-41d9-b214-aab6ccb02dd5 2025-07-01 Warnings Exact identifier application number: M020 Bath and Body Works SPF Tahiti Isle AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 38d049b4-557f-724a-e063-6394a90a19b3 2025-06-30 Warnings Exact identifier application number: M020 Bath and Body Works SPF Tahiti Isle AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 2f74965f-3c84-0590-e063-6294a90af267 2025-06-30 Warnings Exact identifier application number: M020 Bath and Body Works SPF Tahiti Isle AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 38d0d165-e981-284a-e063-6294a90acace 2025-06-30 Warnings Exact identifier application number: M020 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKIN AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc a3dc6195-3011-4e7f-b1b0-0c815b11ba8d 2025-06-30 Warnings Exact identifier application number: M020 Youth to the People Youthscreen Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE AND OCTISALATE LOreal USA Products Inc 5712df74-5201-474b-bbfd-703f3117bd9c 2025-06-30 Warnings Exact identifier application number: M020 BINDA Vitamin C and hyaluronic acid Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38bff6d0-5690-3ee5-e063-6294a90a9faa 2025-06-29 Warnings Exact identifier application number: M020 Vertra S Dorian Kona Gold Signature Face Stick SPF 38 TITANIUM DIOXIDE Toshiki Pigment Co., ltd. b7162a2f-07f1-6188-e053-2995a90a8a9c 2025-06-27 Warnings Exact identifier application number: M020 Orchidee Double Defense Skin Shield OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 74b3c33f-5db5-460d-97be-fa495b625249 2025-06-27 Warnings Exact identifier application number: M020 GHOSTED ZINC OXIDE Spooge a5b611c3-d4d3-461e-84d8-d04a29c74902 2025-06-26 Warnings Exact identifier application number: M020 Dew Me ZINC OXIDE Spooge 0c4b429b-7dd5-4929-95af-d02b6770f121 2025-06-26 Warnings Exact identifier application number: M020 Zinc FIVE-0 baby and kids mineral sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38744f77-4845-eac4-e063-6294a90af648 2025-06-26 Warnings Exact identifier application number: M020 NYU Langone Health Lip Balm ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 38745b55-8da5-4627-e063-6394a90a24ca 2025-06-26 Warnings Exact identifier application number: M020 Active Skin Repair hydrating daily sunscreen ZINC OXIDE Innovacyn, Inc. 1eacdde1-f990-4962-92f1-3f41a8a3b193 2025-06-26 Warnings Exact identifier application number: M020 Cheeky ZINC OXIDE Spooge d377379a-a1be-4acf-9df5-2ff73fb5c83d 2025-06-26 Warnings Exact identifier application number: M020 TheOG ZINC OXIDE Spooge a2f781a8-eba8-48f5-8680-9235aae8a4ff 2025-06-26 Warnings Exact identifier application number: M020 Reef safe - Vitamin C sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f0763-74e9-3a71-e063-6394a90a46fb 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - acne-prone sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f079c-5730-5111-e063-6394a90af2d8 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Zinc Face sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f0f79-016f-71a7-e063-6394a90a9286 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Baby zinc sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f320c-9144-78b8-e063-6394a90a2e9d 2025-06-25 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