FDA.reportPublic FDA data

Tinted Physical Block Sunscreen

Product NDC
85301-203
11-digit product format
853010203
Labeler code
85301
Product ID
85301-203_4586bdad-d8e3-192e-e063-6294a90a6e66
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
85301-203-15Tinted Physical Block Sunscreen1.5 g in 1 PACKETCREAM1.52
85301-203-50Tinted Physical Block Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85301-203TINTED PHYSICAL BLOCK SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [TUCSON ACNE CLINIC]1Current NDC, 1 package rows20250323_30ddf80c-8496-0f47-e063-6394a90afc18.zip
85301-203TINTED PHYSICAL BLOCK SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [TUCSON ACNE CLINIC]1Current NDC, 1 package rows20250323_30ddc3d7-76df-3344-e063-6294a90a65ae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85301-203-15853010203151.5 g in 1 PACKET (85301-203-15) 1.5 g2024-01-22YesNoCurrent
85301-203-508530102035053 g in 1 BOTTLE, PUMP (85301-203-50) 53 g2024-01-22NoNoCurrent