FDA.reportPublic FDA data

DOMINAS DARK SPOT TINTED SUNSCREEN

Product NDC
53208-302
11-digit product format
532080302
Labeler code
53208
Product ID
53208-302_311ce9f8-a489-590a-e063-6294a90a52b8
Type
HUMAN OTC DRUG
Nonproprietary name
Octisalate, Octocrylene, Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
LG H&H CO., LTD.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-25
Substance
OCTISALATE; OCTOCRYLENE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
2.5; 4; 1.53; 8.73 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOMINAS DARK SPOT TINTED SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE2.5 g/100g
OCTOCRYLENE4 g/100g
TITANIUM DIOXIDE1.53 g/100g
ZINC OXIDE8.73 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, 5A68WGF6WM, 15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-302-01DOMINAS DARK SPOT TINTED SUNSCREEN50 g in 1 TUBECREAM502
53208-302-02DOMINAS DARK SPOT TINTED SUNSCREEN1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-302DOMINAS DARK SPOT TINTED SUNSCREEN (OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LG H&H CO., LTD.]2Current NDC, 2 package rows20250327_2b6140cf-7e34-1658-e063-6394a90a3271.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53208-302-015320803020150 g in 1 TUBE50 gHistorical
53208-302-02532080302021 TUBE in 1 CARTON (53208-302-02) / 50 g in 1 TUBE (53208-302-01) 1 tube2025-03-25NoNoHistorical