SPF 30 - Zinc Oxide Lip Balm

Product NDC
63645-184
11-digit product format
636450184
Labeler code
63645
Product ID
63645-184_340695fd-9754-d58a-e063-6294a90a75c9
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
OraLabs
Application
352
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-03
Substance
ZINC OXIDE
Active strength
150 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SPF 30 - Zinc Oxide Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE150 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-184-01SPF 30 - Zinc Oxide Lip Balm4 g in 1 CONTAINERSTICK41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-184SPF 30 - ZINC OXIDE LIP BALM (ZINC OXIDE) STICK [ORALABS]1Current NDC, 1 package rows20250502_482aeef8-8042-4b47-8dbf-ea7687acc5dd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63645-184-01636450184014 g in 1 CONTAINER (63645-184-01) 4 g2025-02-03NoNoCurrent