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 103 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREEN ZINC OXIDE, TITANIUM DIOXIDE LABORATOIRES DERMO-COSMETIK INC. 468c90d7-3b9e-1641-e063-6394a90a928c 2025-12-22 Warnings Exact identifier application number: M020 TiZO3 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals Ltd. 468d6476-127a-e9f0-e063-6294a90a3df9 2025-12-22 Warnings Exact identifier application number: M020 YOUR SKIN BUT BETTER FAIR TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC 3e65ec1a-0ed9-433d-8da9-a6cb61829911 2025-12-22 Warnings Exact identifier application number: M020 Sun Shades Sunscreen Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Melaleuca Inc. 1f982f03-9542-29f9-e063-6294a90a959c 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTED ZINC OXIDE SOLARA SUNCARE, INC. ca99b8c4-6778-43dc-bdd5-ca4a470860a0 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTED ZINC OXIDE SOLARA SUNCARE, INC. f810843b-5a4d-6cbc-e053-6294a90ac9e3 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTED ZINC OXIDE SOLARA SUNCARE, INC. 7a5644b9-4368-4e9a-aa22-b3307acf43cc 2025-12-22 Warnings Exact identifier application number: M020 MINERAL DEFENSE SPORT CERAMIDE SPF-30 ZINC OXIDE SOLARA SUNCARE, INC. cbf9c715-2d45-4c1b-b58f-42795722821c 2025-12-22 Warnings Exact identifier application number: M020 SPF 50 Baby Sunscreen Equate AVOBENZONE, HOMOSALATE, OCTOCRYLENE Walmart Inc 4690d89b-ae61-2ed5-e063-6294a90a743f 2025-12-22 Warnings Exact identifier application number: M020 MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50 ZINC OXIDE SOLARA SUNCARE, INC. f5242c7d-09e1-4141-8de1-a89bd7981ca6 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - TIME TRAVELER SPF-30 UNSCENTED ZINC OXIDE SOLARA SUNCARE, INC. f7ad1b52-6d9d-4a12-a6ab-6584ffc39cc9 2025-12-22 Warnings Exact identifier application number: M020 Go Daily Defense Soothing Mineral Face Sunscreen SPF-30 ZINC OXIDE SOLARA SUNCARE, INC. fd040893-b1e5-783f-e053-6294a90ac216 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - CLEAN FREAK SPF-30 UNSCENTED ZINC OXIDE SOLARA SUNCARE, INC. 0fc8fadf-69fc-40ad-b4ca-d96dd2b30f95 2025-12-22 Warnings Exact identifier application number: M020 GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK SPF-50 ZINC OXIDE SOLARA SUNCARE, INC. f3bb46e8-a9a5-b184-e053-2995a90afca7 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - POUT PROTECTOR SPF-15 ZINC OXIDE SOLARA SUNCARE, INC. ab6a326d-3b93-4122-a9f2-05e8203d31ef 2025-12-22 Warnings Exact identifier application number: M020 SOLARA SUNCARE - FORTUNE TELLER SPF-30 ZINC OXIDE SOLARA SUNCARE, INC. f434de33-5da8-57ef-e053-2a95a90a8502 2025-12-22 Warnings Exact identifier application number: M020 SPF 50 Kids Sunscreen Equate AVOBENZONE, HOMOSALATE, OCTOCRYLENE Walmart Inc 46919f43-2dee-57b1-e063-6294a90a15eb 2025-12-22 Warnings Exact identifier application number: M020 SPF 30 Sport Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Walmart Inc 46919f45-e3f3-4ed0-e063-6294a90a9835 2025-12-22 Warnings Exact identifier application number: M020 Sugargirl Glowy SPF 30 Face Screen daybreak Shimmer Sunscreen for the face HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONE Longway Technology(Guangzhou)Co.,Ltd. 451bb734-d54d-e24e-e063-6394a90a1adb 2025-12-21 Warnings Exact identifier application number: M020 CabanaClear Illuminating SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE NAKED SUNDAYS PTY LTD 47d1a39e-f645-c33d-e063-6394a90ad1ef 2025-12-21 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