Non-tinted Physical Block Sunscreen

Product NDC
85301-202
11-digit product format
853010202
Labeler code
85301
Product ID
85301-202_4586adda-7cb8-00c2-e063-6294a90a8ca9
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
Non-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
85301-202-50Non-tinted Physical Block Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85301-202NON-TINTED PHYSICAL BLOCK SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [TUCSON ACNE CLINIC]1Current NDC, 1 package rows20250323_30dd2f6b-5dcc-b081-e063-6394a90ae5f1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85301-202-508530102025053 g in 1 BOTTLE, PUMP (85301-202-50) 53 g2024-01-22NoNoCurrent