FDA.reportPublic FDA data

Standard Procedure Lip Balm SPF 50

Product NDC
84425-105
11-digit product format
844250105
Labeler code
84425
Product ID
84425-105_4862ec5d-eeef-2171-e063-6294a90ae506
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide Homosalate Octocrylene
Dosage form
STICK
Route
TOPICAL
Labeler
Standard Procedure Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-22
Substance
HOMOSALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
60; 30; 80 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct84425-105DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage84425-10584425-105-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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 Lip Balm SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE60 mg/mL
OCTOCRYLENE30 mg/mL
ZINC OXIDE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e3db995-b1c5-3a2e-e063-6294a90af75eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84425-105-05Standard Procedure Lip Balm SPF 505 mL in 1 TUBESTICK53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84425-105STANDARD PROCEDURE LIP BALM SPF 50 (ZINC OXIDE HOMOSALATE OCTOCRYLENE) STICK [STANDARD PROCEDURE INC]1Current NDC, 1 package rows20240821_1e3db995-b1c5-3a2e-e063-6294a90af75e.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 49 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN BRIGHTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.8de4ec46-f60a-4c51-a16e-9140150e21622026-04-01WarningsExact identifier
application number: M020
ChapStick Moisturizer Cool Mint SPF 15SPF 15 LIP PROTECTANTSuave Brands Co., LLC42f50497-ded1-6863-e063-6294a90a39c82026-03-31WarningsExact identifier
application number: M020
Purito Sunday Adventure Sunscreen SPF 50, 50 mLAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHinaturebf16f535-97fc-4fd8-9310-8b6bbc82baae2026-03-31WarningsExact identifier
application number: M020
spf 50 mineral powder sunscreenTITANIUM DIOXIDE, ZINC OXIDESmalls Brand LLC DBA Roe Wellnessf8762dd1-0484-74ea-e053-6294a90ac1122026-03-31WarningsExact identifier
application number: M020
Badger SPF 30 Face Mineral SunscreenZINC OXIDEW.S. Badger Company, Inc.14a9b605-f1f0-00e5-e063-6394a90a5a512026-03-31WarningsExact identifier
application number: M020
Covergirl cgsmoothers BB Tinted Moisturizer Broad Spectrum SPF 21 (all shades)OCTINOXATE AND ZINC OXIDENoxell Corporation38bba282-b4f7-4374-8732-419400b1cc502026-03-31WarningsExact identifier
application number: M020
SeranovaTM ULTRALIGHT SPF50 SERUMSERANOVATM ULTRALIGHT SPF50 SERUMGuangzhou Ariel Biotech Co., Ltd.4e5d716d-2b2d-d42f-e063-6294a90a1e522026-03-31WarningsExact identifier
application number: M020
ageLOC Tru Face Radiant DayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENENSE Products, Inc.3e9a0b39-4351-41df-81b2-88c1c15c0db22026-03-31WarningsExact identifier
application number: M020
Sunright Solar Screen Mineral Face SunscreenZINC OXIDENSE Products, Inc.93a32040-3a47-4d6f-baa1-5a4595bef4102026-03-31WarningsExact identifier
application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance DayAVOBENZONE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc28f500e2-41d1-4747-8f26-3f6f8cc1b5832026-03-30WarningsExact identifier
application number: M020
Lancome Paris Renergie HPN 300 Peptide Sunscreen Broad Spectrum SPF 25 High-Performance DayAVOBENZONE, OCTISALATE, AND OCTOCRYLENESICOS ET CIEdd448b7a-2554-4dfc-9eb3-ec3486ec61972026-03-30WarningsExact identifier
application number: M020
ANUA MINERAL WEIGHTLESS FINISH SUNSCREENZINC OXIDEThefounders4e37d291-84fb-252a-e063-6294a90acd1f2026-03-30WarningsExact identifier
application number: M020
Beyond Glow Tinted Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDETHE AVON COMPANY4e43bea2-247d-fe11-e063-6294a90a33a32026-03-30WarningsExact identifier
application number: M020
Abib Quick sunstick Protection barHOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONEFOURCOMPANY CO., LTD.1a2ab632-643f-1aa9-e063-6394a90a0c052026-03-30WarningsExact identifier
application number: M020
ChapStick Classic Original MilitarySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4514490b-f348-4526-e063-6294a90ad5052026-03-30WarningsExact identifier
application number: M020
ChapStick Moisturizer Black Cherry SPF 15SPF 15 SKIN PROTECTANTSuave Brands Co., LLC42f40978-51ca-f448-e063-6294a90acf312026-03-30WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen SPF 50NON- NANO ZINC OXIDEDelta Ecommerce LLC473a6ade-1f0a-c711-e063-6294a90a2b832026-03-30WarningsExact identifier
application number: M020
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.0c4e6fa1-c78d-4f9d-969f-135d4ed67daf2026-03-30WarningsExact identifier
application number: M020
Marie originals - ProActive SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4e3204bf-eda4-2bdf-e063-6394a90ae4292026-03-29WarningsExact identifier
application number: M020
Sport UltraAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER37c5dcf7-dc2d-624f-e063-6394a90ae9922026-03-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84425-105-05844250105055 mL in 1 TUBE (84425-105-05) 5 ml2024-07-22NoNoCurrent