FDA.reportPublic FDA data

Dr.Ceuracle HYDRA BARRIER SUNSCREEN

Product NDC
84773-001
11-digit product format
847730001
Labeler code
84773
Product ID
84773-001_32a42694-620d-fddb-e063-6294a90ad623
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Leegeehaam Cosmetics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
Substance
ZINC OXIDE
Active strength
170 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dr.Ceuracle HYDRA BARRIER SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE170 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84773-001-01Dr.Ceuracle HYDRA BARRIER SUNSCREEN50 mL in 1 TUBELOTION502
84773-001-02Dr.Ceuracle HYDRA BARRIER SUNSCREEN1 in 1 PACKAGELOTION12
84773-001-03Dr.Ceuracle HYDRA BARRIER SUNSCREEN10 in 1 BOXLOTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84773-001DR.CEURACLE HYDRA BARRIER SUNSCREEN (ZINC OXIDE) LOTION [LEEGEEHAAM COSMETICS]2Current NDC, 3 package rows20250418_22c05215-4983-b32e-e063-6394a90a9f67.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84773-001-018477300010150 mL in 1 TUBE50 mlHistorical
84773-001-02847730001021 in 1 PACKAGEHistorical
84773-001-038477300010310 PACKAGE in 1 BOX (84773-001-03) / 1 TUBE in 1 PACKAGE (84773-001-02) / 50 mL in 1 TUBE (84773-001-01) 10 package2025-02-01NoNoHistorical