Tinted Mineral Sunscreen

Product NDC
85318-201
11-digit product format
853180201
Labeler code
85318
Product ID
85318-201_45876b4d-9f2f-e8d0-e063-6394a90aa503
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Maloney Plastic Surgery Skin Care, PLLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-03
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
85318-201-85Tinted Mineral Sunscreen85 g in 1 BOTTLE, PUMPCREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85318-201TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALONEY PLASTIC SURGERY SKIN CARE, PLLC]1Current NDC, 1 package rows20250331_316b46ac-6dde-72d1-e063-6294a90a03da.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85318-201-858531802018585 g in 1 BOTTLE, PUMP (85318-201-85) 85 g2022-08-03NoNoCurrent