Tinted Lip Balm

Product NDC
85362-212
11-digit product format
853620212
Labeler code
85362
Product ID
85362-212_4603db8e-2444-c231-e063-6294a90a31bf
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Goldberg, Howard S MD Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-07
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
40; 55 mg/g; 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
Tinted Lip Balm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE40 mg/g
ZINC OXIDE55 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85362-212-45Tinted Lip Balm4.5 g in 1 CYLINDERSTICK4.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85362-212TINTED LIP BALM (TITANIUM DIOXIDE, ZINC OXIDE) STICK [GOLDBERG, HOWARD S MD INC]1Current NDC, 1 package rows20250523_3598205d-2e87-9292-e063-6294a90a1f2a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85362-212-45853620212454.5 g in 1 CYLINDER (85362-212-45) 4.5 g2025-01-07NoNoCurrent