TINTED MINERAL SUNSCREEN SPF 40

Product NDC
85344-203
11-digit product format
853440203
Labeler code
85344
Product ID
85344-203_45c8ee30-4b75-9540-e063-6294a90af8a1
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
DERMATOLOGY ARTS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-17
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 MINERAL SUNSCREEN SPF 40
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
85344-203-50TINTED MINERAL SUNSCREEN SPF 4053 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85344-203TINTED MINERAL SUNSCREEN SPF 40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [DERMATOLOGY ARTS]1Current NDC, 1 package rows20250521_35814d5d-fd34-05b3-e063-6294a90aadd1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85344-203-508534402035053 g in 1 BOTTLE, PUMP (85344-203-50) 53 g2022-03-17NoNoHistorical