Tinted Lip Sunscreen

Product NDC
85596-212
11-digit product format
855960212
Labeler code
85596
Product ID
85596-212_46051f34-ad4f-3921-e063-6394a90a63da
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
LAURA CATHERINE, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-08
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 Sunscreen
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
85596-212-45Tinted Lip Sunscreen4.5 g in 1 CYLINDERSTICK4.52
85596-212-45Tinted Lip Sunscreen1 in 1 CARTONSTICK12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85596-212-45855960212451 CYLINDER in 1 CARTON (85596-212-45) / 4.5 g in 1 CYLINDER1 cylinder2022-04-08NoNoCurrent