Tinted Mineral Sunscreen

Product NDC
85414-201
11-digit product format
854140201
Labeler code
85414
Product ID
85414-201_459b7e47-36a8-ad1a-e063-6294a90aa550
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Hirschman, Kristina
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-08
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
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
85414-201-85Tinted Mineral Sunscreen85 g in 1 BOTTLE, PLASTICCREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85414-201TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HIRSCHMAN, KRISTINA]1Current NDC, 1 package rows20250523_35ba578f-a842-7eec-e063-6394a90a1165.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85414-201-858541402018585 g in 1 BOTTLE, PLASTIC (85414-201-85) 85 g2023-11-08NoNoHistorical