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 21 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
application number: M020
TERRA LOTUS SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC53c09714-6137-7102-e063-6294a90a72a42026-06-08WarningsExact identifier
application number: M020
TITAN TALLOW SPF 50 ORGANIC TALLOW SUNSCREENZINC OXIDEMoes Group LLC53c13cc3-208e-ae7d-e063-6294a90a2a032026-06-08WarningsExact identifier
application number: M020
Innisfree Daily UV Defense Mineral SunscreenZINC OXIDE LOTIONInnisfree Corporation0e9cd3e5-cff8-7594-e063-6394a90aad902026-06-08WarningsExact identifier
application number: M020
Paulas Choice Lipscreen Broad Spectrum SPF 50OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENECosmetic Solutions LLC4c37e10c-3da5-4a48-b2c1-1b99ce9a02c12026-06-08WarningsExact identifier
application number: M020
Eryfotona Ageless Tinted Lightweight Emulsion SunscreenTITANIUM DIOXIDEISDIN Corp.293a1116-e8a2-495f-83db-20dd82ed13c22026-06-08WarningsExact identifier
application number: M020
Inflair Elevate SPF15 MoisturizerETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE HOMOSALATE BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Yapheon Health Industry Co., Ltd53a724e9-229e-eea4-e063-6294a90a7d5e2026-06-07WarningsExact identifier
application number: M020
Eryfotona Actinica TintedTITANIUM DIOXIDEISDIN Corp.97357703-0e93-4216-bd1b-a9b2027819592026-06-05WarningsExact identifier
application number: M020
Invisible Fit Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.537cb611-52f4-13a5-e063-6294a90a9f2a2026-06-05WarningsExact identifier
application number: M020
Matte Invisible Mineral SunscreenZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC538429b8-4f0e-e825-e063-6294a90a59052026-06-05WarningsExact identifier
application number: M020
Matte Invisible Mineral Sunscreen Non-TintedZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC5384da3c-4017-a3c1-e063-6294a90ae9a32026-06-05WarningsExact identifier
application number: M020
MEDULTIMA ADVENTURE SUNSCREENHOMOSALATE,OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Tata Biotechnology Co., Ltd.5368b2b3-fd80-9659-e063-6394a90a0ad32026-06-04WarningsExact identifier
application number: M020
WEN SixThirteen SPF 20 Dry Oil Intensive TreatmentOCTOCRYLENE, HOMOSALATE, ETHYLHEXYL METHOCINNAMATE, ETHYLHEXYL SALICYLATE, BENZOPHENONEWEN by Chaz Dean536e6291-f5ca-37a4-e063-6394a90adfdb2026-06-04WarningsExact identifier
application number: M020
Mineral Mattescreen SPF 40 - UntintedTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC08671d39-3be2-d666-e063-6294a90a62072026-06-04WarningsExact identifier
application number: M020
Mineral Mattescreen SPF 40 - Golden HourTITANIUM DIOXIDE, ZINC OXIDESupergoop, LLCc2398820-f003-707f-e053-2a95a90a69292026-06-04WarningsExact identifier
application number: M020
Glow Gloss Lip Balm SPF 40 Vanilla Soft ServeHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATESupergoop!26d2897f-46a7-52b2-e063-6394a90aed322026-06-04WarningsExact identifier
application number: M020
Epionce Daily Shield Tinted SPF 50TITANIUM DIOXIDE, ZINC OXIDEEpisciences, Inc.3d1e2921-cba9-4446-e054-00144ff8d46c2026-06-04WarningsExact identifier
application number: M020
Abib No White Cast SPF Gift SetHOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.537420bb-9fd8-0649-e063-6394a90aa8cf2026-06-04WarningsExact identifier
application number: M020
Airy sunstick smooting barHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.f8203d54-cd3d-314d-e053-6394a90ac10d2026-06-04WarningsExact identifier
application number: M020
Play Everyday Sunscreen SPF 50 with Sunflower ExtractAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC0428eebc-4ffb-4981-b738-2c9ecf2a6a2e2026-06-04WarningsExact 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