Lip Balm

Product NDC
85649-212
11-digit product format
856490212
Labeler code
85649
Product ID
85649-212_46284e55-cb55-f3f4-e063-6394a90a201b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
PATRICIA SOLIS MAKEUP ARTIST, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-03
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 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
85649-212-45Lip Balm1 in 1 CARTONSTICK12
85649-212-45Lip Balm4.5 g in 1 CYLINDERSTICK4.52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85649-212-45856490212451 CYLINDER in 1 CARTON (85649-212-45) / 4.5 g in 1 CYLINDER1 cylinder2021-06-03NoNoHistorical