Mineral Primer non-tinted SPF40

Product NDC
85356-202
11-digit product format
853560202
Labeler code
85356
Product ID
85356-202_46001e21-4f17-a71b-e063-6294a90a6fc9
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Oracle Esthetics, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-18
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
Mineral Primer non-tinted SPF40
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
85356-202-50Mineral Primer non-tinted SPF4053 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85356-202MINERAL PRIMER NON-TINTED SPF40 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [ORACLE ESTHETICS, LLC]1Current NDC, 1 package rows20250519_354357de-1a85-3bdb-e063-6294a90aa9a2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85356-202-508535602025053 g in 1 BOTTLE, PUMP (85356-202-50) 53 g2020-05-18NoNoHistorical