FDA.reportPublic FDA data

Ultra Zinc Mineral Non Tinted

Product NDC
85357-205
11-digit product format
853570205
Labeler code
85357
Product ID
85357-205_46002ad3-8c61-8593-e063-6394a90a6b67
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Skin Therapy Studio LLC�
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-13
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
Ultra Zinc Mineral Non Tinted
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
85357-205-04Ultra Zinc Mineral Non Tinted113 g in 1 BOTTLE, PUMPCREAM1132
85357-205-15Ultra Zinc Mineral Non Tinted1.5 g in 1 PACKETCREAM1.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85357-205ULTRA ZINC MINERAL NON TINTED (ZINC OXIDE) CREAM [SKIN THERAPY STUDIO LLC ]1Current NDC, 1 package rows20250521_35806102-6919-116f-e063-6294a90ad922.zip
85357-205ULTRA ZINC MINERAL NON TINTED (ZINC OXIDE) CREAM [SKIN THERAPY STUDIO LLC ]1Current NDC, 1 package rows20250519_3545d603-3d01-c51d-e063-6394a90a1599.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85357-205-0485357020504113 g in 1 BOTTLE, PUMP (85357-205-04) 113 g2024-03-13NoNoHistorical
85357-205-15853570205151.5 g in 1 PACKET (85357-205-15) 1.5 g2024-03-13YesNoHistorical