FDA.reportPublic FDA data

Tinted Replenishing Daily Protection

Product NDC
85377-208
11-digit product format
853770208
Labeler code
85377
Product ID
85377-208_45ffabea-6e6f-930a-e063-6294a90a6df1
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
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
Tinted Replenishing Daily Protection
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
85377-208-15Tinted Replenishing Daily Protection1.5 g in 1 PACKETCREAM1.52
85377-208-50Tinted Replenishing Daily Protection50 g in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85377-208TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA]1Current NDC, 1 package rows20250426_338aa5a2-29e3-fe0e-e063-6294a90a18fd.zip
85377-208TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA]1Current NDC, 1 package rows20250426_33898415-4ee6-a384-e063-6394a90ae8e1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85377-208-15853770208151.5 g in 1 PACKET (85377-208-15) 1.5 g2023-03-31YesNoCurrent
85377-208-508537702085050 g in 1 BOTTLE, PUMP (85377-208-50) 50 g2023-03-31NoNoCurrent