Tinted Mineral Sunscreen

Product NDC
85414-203
11-digit product format
854140203
Labeler code
85414
Product ID
85414-203_459b7c47-9373-a616-e063-6294a90ac4cb
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
85414-203-15Tinted Mineral Sunscreen15 g in 1 PACKETCREAM152
85414-203-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85414-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HIRSCHMAN, KRISTINA]1Current NDC, 1 package rows20250524_35bd61ff-0d66-a9b3-e063-6394a90ad940.zip
85414-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HIRSCHMAN, KRISTINA]1Current NDC, 1 package rows20250523_35bafa0b-d253-c263-e063-6394a90ad1e4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85414-203-158541402031515 g in 1 PACKET (85414-203-15) 15 g2023-11-13YesNoHistorical
85414-203-508541402035053 g in 1 BOTTLE, PUMP (85414-203-50) 53 g2023-11-08NoNoHistorical