FDA.reportPublic FDA data

Mineral Sunscreen 20percent Zinc Oxide

Product NDC
85377-205
11-digit product format
853770205
Labeler code
85377
Product ID
85377-205_45ffaa19-26bf-d41f-e063-6394a90ad7c3
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
MANTRA WELLNESS SPA
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-31
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
Mineral Sunscreen 20percent Zinc Oxide
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
85377-205-04Mineral Sunscreen 20percent Zinc Oxide113 g in 1 BOTTLE, PUMPCREAM1132
85377-205-15Mineral Sunscreen 20percent Zinc Oxide1.5 g in 1 PACKETCREAM1.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85377-205MINERAL SUNSCREEN 20PERCENT ZINC OXIDE (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA]1Current NDC, 1 package rows20250426_338a11fb-24c6-8a0b-e063-6294a90a761e.zip
85377-205MINERAL SUNSCREEN 20PERCENT ZINC OXIDE (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA]1Current NDC, 1 package rows20250426_338855fd-3008-44d9-e063-6294a90a5e07.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85377-205-0485377020504113 g in 1 BOTTLE, PUMP (85377-205-04) 113 g2023-03-31NoNoHistorical
85377-205-15853770205151.5 g in 1 PACKET (85377-205-15) 1.5 g2023-03-31YesNoHistorical