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 232 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TiZO Ultra Zinc SPF 40 (Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD 2d0856cf-d3da-5a77-e063-6294a90ad5b4 2025-01-31 Warnings Exact identifier application number: M020 FRE PROTECT BODY Ultra-Light Gel Cream SPF 50 ZINC OXIDE Peer Pharm Ltd. 2cd83c55-851c-089e-e063-6294a90ad6bc 2025-01-30 Warnings Exact identifier application number: M020 FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 ZINC OXIDE Peer Pharm Ltd. 2cd958a3-bad6-725e-e063-6294a90a8578 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30 ZINC OXIDE Peer Pharm Ltd. 2cd77d62-77df-f3a9-e063-6394a90ad57d 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT PAMPELONNE SPF 30 ZINC OXIDE Peer Pharm Ltd. 2caf3b6b-3a05-b24a-e063-6394a90a4799 2025-01-30 Warnings Exact identifier application number: M020 Jil Goorman Skincare Sun Guard SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SAN DIEGO NATURAL SOAP COMPANY 9a088bed-3b85-4bf5-923b-4c99eb904a8d 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 ZINC OXIDE Peer Pharm Ltd. 2baf0278-7e13-4db0-e063-6294a90ae9de 2025-01-30 Warnings Exact identifier application number: M020 Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50 ZINC OXIDE Babo Botanicals, Inc. 08a175ae-2307-ef8d-e063-6394a90ad234 2025-01-30 Warnings Exact identifier application number: M020 Babo Botanicals Super Shield Mineral Sunscreen SPF50 ZINC OXIDE Babo Botanicals, Inc 08b7bcfd-0c7c-a14f-e063-6294a90a7797 2025-01-30 Warnings Exact identifier application number: M020 Salt and Stone Sunscreen Lip Balm SPF 30 ZINC OXIDE Salt and Stone LLC b555aa10-1547-63cc-e053-2995a90ad20d 2025-01-30 Warnings Exact identifier application number: M020 COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIR OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE Bluemercury 5c590aed-d2f2-4478-8919-37c848752b42 2025-01-29 Warnings Exact identifier application number: M020 LiProtect SPF 35 ZINC OXIDE, TITANIUM DIOXIDE Science of Skincare 0d0a2657-4098-3c60-e063-6294a90acabb 2025-01-29 Warnings Exact identifier application number: M020 Perfect Sunscreen Tinted Mineral SPF50 ZINC OXIDE Bluemercury, Inc. 4c978154-679f-472a-95ab-56878c5c70cd 2025-01-29 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE BELLE MEDICAL LLC 2cdc69d3-2192-7a38-e063-6294a90a257f 2025-01-29 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Boxbar Beauty LLC 2d04c5e7-f3aa-873f-e063-6294a90a33d2 2025-01-29 Warnings Exact identifier application number: M020 SEAWEED BATH CO. Super Sheer Face Serum SPF-50 ZINC OXIDE The Seaweed Bath Co. a45b46f9-681f-4a8d-b561-165b995ccf80 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish Non-Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc62961-dcef-d7db-e063-6394a90a9ebd 2025-01-28 Warnings Exact identifier application number: M020 Every Sun Day Ultra-Sheer Priming Sunscreen Stick AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Have & Be Co., Ltd. 2b53aa68-9c05-1682-e063-6294a90a968c 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc73c4f-30ea-0a51-e063-6394a90ac9a4 2025-01-28 Warnings Exact identifier application number: M020 TiZO Photoceutical AM Replenish - Tinted ZINC OXIDE Fallien Cosmeceuticals, LTD 2cc84aba-006b-a78e-e063-6294a90ae040 2025-01-28 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