Mineral Tinted Lip Sunscreen

Product NDC
85620-212
11-digit product format
856200212
Labeler code
85620
Product ID
85620-212_4604bcf1-6b16-a71e-e063-6394a90acd8a
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
JADEIA LIMITED INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-22
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 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
85620-212-45Mineral Tinted Lip Sunscreen4.5 g in 1 CYLINDERSTICK4.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85620-212MINERAL TINTED LIP SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [JADEIA LIMITED INC]1Current NDC, 1 package rows20250524_35cf36c1-50c9-e848-e063-6294a90a6658.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85620-212-45856200212454.5 g in 1 CYLINDER (85620-212-45) 4.5 g2024-02-22NoNoHistorical