Home NDC 84425-105 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 84425-105 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 84425-105 84425-105-05 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…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 Ingredient Strength HOMOSALATE 60 mg/mL OCTOCRYLENE 30 mg/mL ZINC OXIDE 80 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 5A68WGF6WM Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84425-105-05 Standard Procedure Lip Balm SPF 50 5 mL in 1 TUBE STICK 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84425-105 STANDARD PROCEDURE LIP BALM SPF 50 (ZINC OXIDE HOMOSALATE OCTOCRYLENE) STICK [STANDARD PROCEDURE INC] 1 Current NDC, 1 package rows 20240821_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 45 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84425-105-05 84425010505 5 mL in 1 TUBE (84425-105-05) 5 ml 2024-07-22 No No Current