FDA.reportPublic FDA data

Tinted Mineral Sunscreen

Product NDC
85327-203
11-digit product format
853270203
Labeler code
85327
Product ID
85327-203_458a488b-636b-ac69-e063-6294a90a9b0f
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Rhonda J Pomerantz MD PLLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-15
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
85327-203-15Tinted Mineral Sunscreen1.5 g in 1 PACKETCREAM1.52
85327-203-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85327-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [RHONDA J POMERANTZ MD PLLC]1Current NDC, 1 package rows20250410_325c3a18-ba8f-912d-e063-6394a90a2447.zip
85327-203TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [RHONDA J POMERANTZ MD PLLC]1Current NDC, 1 package rows20250410_325c8641-1161-b8ac-e063-6394a90ae451.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85327-203-15853270203151.5 g in 1 PACKET (85327-203-15) 1.5 g2021-12-15YesNoHistorical
85327-203-508532702035053 g in 1 BOTTLE, PUMP (85327-203-50) 53 g2021-12-15NoNoHistorical