FDA.reportPublic FDA data

Superscreen Daytime Mineral Sunscreen

Product NDC
85449-208
11-digit product format
854490208
Labeler code
85449
Product ID
85449-208_460097a6-d949-13cb-e063-6394a90ab585
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-08
Substance
ZINC OXIDE
Active strength
160 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
Superscreen Daytime Mineral Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85449-208-15Superscreen Daytime Mineral Sunscreen1.5 g in 1 PACKETCREAM1.52
85449-208-50Superscreen Daytime Mineral Sunscreen50 g in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85449-208SUPERSCREEN DAYTIME MINERAL SUNSCREEN (ZINC OXIDE) CREAM [MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY]1Current NDC, 1 package rows20250521_35805e66-18e6-0e45-e063-6294a90afe58.zip
85449-208SUPERSCREEN DAYTIME MINERAL SUNSCREEN (ZINC OXIDE) CREAM [MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY]1Current NDC, 1 package rows20250521_357f915a-bd77-350b-e063-6294a90ad27f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85449-208-15854490208151.5 g in 1 PACKET (85449-208-15) 1.5 g2024-10-23YesNoHistorical
85449-208-508544902085050 g in 1 BOTTLE, PUMP (85449-208-50) 50 g2023-11-08NoNoHistorical