Lip Protection

Product NDC
85339-212
11-digit product format
853390212
Labeler code
85339
Product ID
85339-212_45b3a9bc-1124-4545-e063-6394a90a5a58
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Teton Dermatology Holdings, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-27
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
Lip Protection
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
85339-212-45Lip Protection1 in 1 CARTONSTICK12
85339-212-45Lip Protection4.5 g in 1 CYLINDERSTICK4.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85339-212LIP PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE) STICK [TETON DERMATOLOGY HOLDINGS, INC.]1Current NDC, 2 package rows20250515_3509eea7-f966-2080-e063-6294a90aeeb5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85339-212-45853390212451 CYLINDER in 1 CARTON (85339-212-45) / 4.5 g in 1 CYLINDER1 cylinder2023-10-27NoNoHistorical