FDA.reportPublic FDA data

Tinted Matte Defense Sunscreen Primer

Product NDC
85533-203
11-digit product format
855330203
Labeler code
85533
Product ID
85533-203_45b4d122-1d1f-1945-e063-6294a90a90bb
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Mint Skin Incorporated
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-06
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 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 Matte Defense Sunscreen Primer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85533-203-15Tinted Matte Defense Sunscreen Primer1.5 g in 1 PACKETCREAM1.52
85533-203-50Tinted Matte Defense Sunscreen Primer53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85533-203TINTED MATTE DEFENSE SUNSCREEN PRIMER (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MINT SKIN INCORPORATED]1Current NDC, 1 package rows20250516_352f8de3-8ff0-4098-e063-6294a90ace4d.zip
85533-203TINTED MATTE DEFENSE SUNSCREEN PRIMER (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MINT SKIN INCROPORATED]1Current NDC, 1 package rows20250516_35305bf1-8947-f275-e063-6294a90a3024.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85533-203-15855330203151.5 g in 1 PACKET (85533-203-15) 1.5 g2021-07-06YesNoHistorical
85533-203-508553302035053 g in 1 BOTTLE, PUMP (85533-203-50) 53 g2021-07-06NoNoHistorical