Tinted Physical Block Sunscreen

Product NDC
85301-201
11-digit product format
853010201
Labeler code
85301
Product ID
85301-201_4586b1ca-b20c-f78a-e063-6394a90a2523
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Tucson Acne Clinic
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-22
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 Physical Block Sunscreen
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
85301-201-85Tinted Physical Block Sunscreen85 g in 1 BOTTLE, PUMPCREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85301-201TINTED PHYSICAL BLOCK SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [TUCSON ACNE CLINIC]1Current NDC, 1 package rows20250323_30dc6e23-ecca-ed0b-e063-6294a90a7951.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85301-201-858530102018585 g in 1 BOTTLE, PUMP (85301-201-85) 85 g2024-01-22NoNoCurrent