FDA.reportPublic FDA data

Ultimate Physical Sunscreen

Product NDC
85413-205
11-digit product format
854130205
Labeler code
85413
Product ID
85413-205_45b3b14f-2c89-5ba1-e063-6394a90a00a2
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
HALEM DERMATOLOGY PLLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-02
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
Ultimate Physical Sunscreen
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
85413-205-04Ultimate Physical Sunscreen113 g in 1 BOTTLE, PUMPCREAM1132
85413-205-13Ultimate Physical Sunscreen113 g in 1 BOTTLE, PUMPCREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85413-205ULTIMATE PHYSICAL SUNSCREEN (ZINC OXIDE) CREAM [HALEM DERMATOLOGY PLLC]1Current NDC, 1 package rows20250529_35be5dc0-861f-3738-e063-6394a90a23ca.zip
85413-205ULTIMATE PHYSICAL SUNSCREEN (ZINC OXIDE) CREAM [HALEM DERMATOLOGY PLLC]1Current NDC, 1 package rows20250523_35bc5ff5-8eb8-54cf-e063-6394a90ae3c2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85413-205-0485413020504113 g in 1 BOTTLE, PUMP (85413-205-04) 113 g2021-12-02NoNoCurrent
85413-205-1385413020513113 g in 1 BOTTLE, PUMP (85413-205-13) 113 g2022-04-12NoNoCurrent