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 184 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Kids mineral STRAWBERRY SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDEThe Natural SKN Company400c67aa-55a6-67ea-e063-6294a90a02132025-09-30WarningsExact identifier
application number: M020
toty Ilumina CC Creamy Compact Refill 1CTITANIUM DIOXIDEChipican LLCf0596830-77ed-11f0-e053-2995a90a8ff52025-09-29WarningsExact identifier
application number: M020
U V-Lamp Shield Mani-SunscreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe7e1c3-e6cd-1420-e063-6394a90a41382025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC053e76f0-8ca0-645d-e063-6394a90a01d22025-09-28WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCcdc54f23-0efb-2fb4-e053-2995a90ae58b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0540017a-52ac-7972-e063-6394a90a139c2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f3b27f-b233-d406-e063-6394a90ada762025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC128a3772-b9b7-0d10-e063-6294a90a3e052025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c82a2-0131-8023-e063-6294a90aba7b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c780a-3107-d71a-e063-6394a90aca252025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC31d01fae-4085-d84a-e063-6294a90ab9812025-09-28WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC3388c2fa-8082-95d4-e063-6294a90a94b82025-09-28WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLCb10a7794-7e4f-412b-9eb2-773107ecb7fc2025-09-26WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Black Girl Sunscreenfed22570-e0ae-43e1-b6ce-1f0ad01684c32025-09-26WarningsExact identifier
application number: M020
Sun Glazed SPF 30 Sunscreen Glow OilAVOBENZONE, HOMOSALATE, OCTOCRYLENEBaxter Laboratories Pty. Ltd.3fa41ed1-2f7f-18e6-e063-6294a90a0a8b2025-09-25WarningsExact identifier
application number: M020
Smooth Even GlowTINTED SUNSCREEN BROAD SPF30SKNVcare, LLC3fa48151-fcb9-3d35-e063-6394a90a2eb62025-09-25WarningsExact identifier
application number: M020
CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVEAVOBENZONE, HOMOSALATE, OCTISALATEMDSolarSciences3fa810b0-0211-f2a7-e063-6294a90a0b722025-09-25WarningsExact identifier
application number: M020
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
application number: M020
HygieneLab Face and Body Mineral Sunscreen SPF 50ZINC OXIDEHYGIENELAB, INC7db103da-b434-433a-a18f-a727165640c02025-09-24WarningsExact identifier
application number: M020
Eve Lom Daily Protection Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENESpace Brands Limited0e2c9ffb-036d-49c5-abdb-2ee8888df3182025-09-24WarningsExact 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