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 158 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Sun Tinted Face SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.22413f93-7219-4726-b741-2392e576b34a2025-11-24WarningsExact identifier
application number: M020
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDEKingdom Animalia, LLC DBA Hourglass Cosmetics28e23498-953f-47c0-838c-bbf0e858d9032025-11-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c9d86-45d7-efcc-e063-6394a90acefb2025-11-23WarningsExact identifier
application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC615c5349-7fff-4145-9d65-1687247163be2025-11-21WarningsExact identifier
application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Face SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3cee59ad-f5e1-487d-b9cc-597664c62dac2025-11-21WarningsExact identifier
application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0e905f47-a1d8-4c5a-8247-d7328d2cb4af2025-11-21WarningsExact identifier
application number: M020
SPF 50 Sport Sunscreen GoodSenseAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Geiss, Destin, & Dunn, Inca22baebd-1f4d-6eae-e053-2a95a90afe512025-11-21WarningsExact identifier
application number: M020
Everyday Sun DefenseZINC OXIDEHommerejuvenate, Inc.05aa1a1a-9e4f-2781-e063-6394a90aef6b2025-11-21WarningsExact identifier
application number: M020
innisfree Daily UV Defense SunscreenAVOBENZONE, HOMOSALATE, AND OCTISALATE LOTIONInnisfree Corporation0e9b6697-28a3-f69f-e063-6394a90a9d112025-11-20WarningsExact identifier
application number: M020
SULWHASOO PERFECTING CUSHION NO. 25OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAmorepacific Corporation8d420e4b-c778-3ed4-e053-2995a90a59a92025-11-20WarningsExact identifier
application number: M020
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDENorwex Usa, Inc.f527a8c5-b05e-5f3c-e053-2995a90aa1a32025-11-20WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 HazelnutZINC OXIDENorwex Usa, Inc.440bd831-ee0b-b527-e063-6294a90a93332025-11-20WarningsExact identifier
application number: M020
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEElemis Ltd.23f9222f-60ba-72fb-e063-6394a90a99652025-11-20WarningsExact identifier
application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie RepellantZINC OXIDE SUNSCREENVEGANIC SKN LIMITED36ca866e-adc3-5a4f-e063-6394a90a1d1d2025-11-20WarningsExact identifier
application number: M020
Sandra Plasencia Green Tea Daily SPF 50 MoisturizerTITANIUM DIOXIDESandra Plasencia Skincare43ef1f93-0e89-0a35-e063-6394a90afb512025-11-19WarningsExact identifier
application number: M020
Sunkissed by Heaven Unscented Sunscreen SPF 50ZINC OXIDESunkissed By Heaven, LLC09dbd05a-dd07-43c3-b3d0-68f8f4b3e86d2025-11-19WarningsExact identifier
application number: M020
KOVR Military grade sunscreen for womenZINC OXIDEACTIVE LIFE INC4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae2025-11-19WarningsExact identifier
application number: M020
Dynamic Resurfacing SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedfc64720c-060c-4f33-8c76-96456fac270d2025-11-19WarningsExact identifier
application number: M020
Daily Defence Shield SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limitedb2b6de93-47c8-4b6e-9fb9-8bdc8909271a2025-11-19WarningsExact identifier
application number: M020
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32ZINC OXIDEDUKE CANNON SUPPLY CO.0c47278b-2ec2-81ab-e063-6294a90ac9372025-11-19WarningsExact 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