Hydrating Mineral Zinc Oxide SPF 40

Product NDC
85360-205
11-digit product format
853600205
Labeler code
85360
Product ID
85360-205_4603ed70-cfc8-cd72-e063-6294a90a6bf0
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Spalina LLC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-08
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
Hydrating Mineral Zinc Oxide SPF 40
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
85360-205-04Hydrating Mineral Zinc Oxide SPF 40113 g in 1 BOTTLE, PUMPCREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85360-205HYDRATING MINERAL ZINC OXIDE SPF 40 (ZINC OXIDE) CREAM [SPALINA LLC.]1Current NDC, 1 package rows20250523_35aa74c5-1bb3-9814-e063-6294a90a6999.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85360-205-0485360020504113 g in 1 BOTTLE, PUMP (85360-205-04) 113 g2019-10-08NoNoCurrent