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

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 Identifiers#

Field, Values table
FieldValues
UniiV06SV4M95S, 5A68WGF6WM, SOI2LOH54Z

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

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