Mineral Lip Sunscreen Tinted

Product NDC
85634-212
11-digit product format
856340212
Labeler code
85634
Product ID
85634-212_45b433c3-b48f-e64e-e063-6394a90a8f45
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-11
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
Mineral Lip Sunscreen Tinted
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
85634-212-45Mineral Lip Sunscreen Tinted1 in 1 CARTONSTICK12
85634-212-45Mineral Lip Sunscreen Tinted4.5 g in 1 CYLINDERSTICK4.52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85634-212-45856340212451 CYLINDER in 1 CARTON (85634-212-45) / 4.5 g in 1 CYLINDER1 cylinder2023-04-11NoNoHistorical