FDA.reportPublic FDA data

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
IngredientStrength
OCTOCRYLENE80 mg/mL
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d3f87de-90c0-75c0-e063-6394a90a2ef4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84425-101-01Standard Procedure SPF 50 Sunscreen60 mL in 1 BOTTLE, PLASTICLOTION602
84425-101-03Standard Procedure SPF 50 Sunscreen250 mL in 1 BOTTLE, PLASTICLOTION2502
84425-101-04Standard Procedure SPF 50 Sunscreen500 mL in 1 BOTTLE, PLASTICLOTION5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84425-101STANDARD PROCEDURE SPF 50 SUNSCREEN (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [STANDARD PROCEDURE INC]1Current NDC, 3 package rows20240821_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 179 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curology The Lip Balm Broad Spectrum SPF 30 SunscreenZINC OXIDECurology Inc.e441b13f-cb58-457f-e053-2a95a90adab92025-10-15WarningsExact identifier
application number: M020
Curology Everyday Sunscreen Broad Spectrum SPF 30 No-clog UV defenseZINC OXIDECurology39a2a297-3af2-40d3-8b5d-f4eef2487fb22025-10-15WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral SunscreenZINC OXIDEColorescience00d8bf32-aecd-22da-e063-6294a90a75672025-10-15WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 SandZINC OXIDECosmetic Enterprises Ltd253c105b-215b-1e6e-e063-6294a90a11d72025-10-14WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 TanZINC OXIDECosmetic Enterprises Ltd265bbb1a-ba96-6598-e063-6394a90a94152025-10-14WarningsExact identifier
application number: M020
Resist Wrinkle Defense SPF 30 Paulas ChoiceZINC OXIDECosmetic Enterprises Ltdd658fdc7-9dac-47bf-8e83-1433a29a6cf62025-10-14WarningsExact identifier
application number: M020
SPF 50 Face Sunscreen BioelementsAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECosmetic Enterprises Ltd498b16c8-ba54-4a0a-8dbc-4b5cc368e2142025-10-14WarningsExact identifier
application number: M020
Skin Balancing Ultra Sheer Daily Defence SPF 30 Paulas ChoiceAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONECosmetic Enterprises Ltd3bf31626-5580-457b-8a59-cc37f4ab07672025-10-14WarningsExact identifier
application number: M020
Sunscreen Broad Spectrum SPF 30 Light Tropical ScentZINC OXIDECosmetic Enterprises Ltdd8c7b82d-6151-2199-e053-2a95a90a6c202025-10-14WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.412975d8-0b8b-23bf-e063-6294a90a55682025-10-14WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.4129e00b-951d-adbf-e063-6294a90a675e2025-10-14WarningsExact identifier
application number: M020
Sunny Sailor First Mate Face Stick SPF 30ZINC OXIDESUNNY SAILOR LLCc7908385-ff93-4c6c-9462-081c730235712025-10-13WarningsExact identifier
application number: M020
Cloud Brush On Sunscreen SPF 50ZINC OXIDEFUTURE 8 LLC8b1eaf6c-9cd8-4c5e-beac-b8539c332ae32025-10-13WarningsExact identifier
application number: M020
Sunplus Mist Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC951a7bdc-d5c5-4241-a482-c30a4b44f7762025-10-13WarningsExact identifier
application number: M020
Sunplus Mist Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLCda338ba7-7a92-4157-97f4-5ae9cc64853c2025-10-13WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 50 Alcohol Free SunscreenOCTOCRYLENE, OCTINOXATE, HOMOSALATE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc998fe524-6469-4c9b-889b-3191882149ce2025-10-13WarningsExact identifier
application number: M020
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 BuffZINC OXIDECosmetic Enterprises Ltd265bc5e0-0a2a-842e-e063-6394a90aae0a2025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 MochaZINC OXIDECosmetic Enterprises Ltd2748b6bc-e80b-ce66-e063-6394a90a400a2025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 BronzeZINC OXIDECosmetic Enterprises Ltd265bf123-c4c3-8414-e063-6394a90a47302025-10-13WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84425-101-018442501010160 mL in 1 BOTTLE, PLASTIC (84425-101-01) 60 ml2024-07-15NoNoCurrent
84425-101-0384425010103250 mL in 1 BOTTLE, PLASTIC (84425-101-03) 250 ml2024-07-15NoNoCurrent
84425-101-0484425010104500 mL in 1 BOTTLE, PLASTIC (84425-101-04) 500 ml2024-07-15NoNoCurrent