Home NDC 53208-302 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; TITANIUM DIOXIDE; OCTOCRYLENE; ZINC OXIDE
Active strength 2.5; 1.53; 4; 8.73 g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DOMINAS DARK SPOT TINTED SUNSCREEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 2.5 g/100g TITANIUM DIOXIDE 1.53 g/100g OCTOCRYLENE 4 g/100g ZINC OXIDE 8.73 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53208-302-01 DOMINAS DARK SPOT TINTED SUNSCREEN 50 g in 1 TUBE CREAM 50 2 53208-302-02 DOMINAS DARK SPOT TINTED SUNSCREEN 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53208-302 DOMINAS DARK SPOT TINTED SUNSCREEN (OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [LG H&H CO., LTD.] 2 Current NDC, 2 package rows 20250327_2b6140cf-7e34-1658-e063-6394a90a3271.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 45 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53208-302-01 53208030201 50 g in 1 TUBE 50 g Historical 53208-302-02 53208030202 1 TUBE in 1 CARTON (53208-302-02) / 50 g in 1 TUBE (53208-302-01) 1 tube 2025-03-25 No No Current