Royal Screen

Product NDC
85616-205
11-digit product format
856160205
Labeler code
85616
Product ID
85616-205_4627f419-5220-38b0-e063-6294a90a5755
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
QUEENIES BEAUTY LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-28
Substance
ZINC OXIDE
Active strength
200 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
Royal Screen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85616-205-04Royal Screen113 g in 1 BOTTLE, PUMPCREAM1132
85616-205-15Royal Screen15 g in 1 PACKETCREAM152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85616-205-0485616020504113 g in 1 BOTTLE, PUMP (85616-205-04) 113 g2022-10-28NoNoHistorical
85616-205-158561602051515 g in 1 PACKET (85616-205-15) 15 g2022-10-28YesNoHistorical