Home NDC 53208-301 Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50
Product NDC 53208-301
11-digit product format 532080301
Labeler code 53208
Product ID 53208-301_47a82656-065a-39ad-e063-6294a90a3d40
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form CREAM
Route TOPICAL
Labeler LG H&H Co.,Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-30
Substance OCTISALATE; HOMOSALATE; AVOBENZONE; OCTOCRYLENE
Active strength 4.5; 9; 2.7; 9 g/50mL; g/50mL; g/50mL; g/50mL
NDC exclude flag No
Listing certified through 2027-12-31
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 UV Defense Sunscreen Broad Spectrum SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 4.5 g/50mL HOMOSALATE 9 g/50mL AVOBENZONE 2.7 g/50mL OCTOCRYLENE 9 g/50mL
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 53208-301-50 Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 1 in 1 CARTON CREAM 1 8 53208-301-50 Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 50 mL in 1 TUBE CREAM 50 8 53208-301-52 Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 50 mL in 1 TUBE CREAM 50 8 53208-301-52 Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50 2 in 1 CARTON CREAM 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53208-301 DOMINAS DARK SPOT UV DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [LG H&H CO.,LTD.] 4 Current NDC, 4 package rows 20240518_098c0a9b-2b96-6be3-e063-6294a90a959a.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 26 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 53208-301-50 53208030150 1 TUBE in 1 CARTON (53208-301-50) / 50 mL in 1 TUBE 1 tube 2023-10-30 No No Current 53208-301-52 53208030152 2 TUBE in 1 CARTON (53208-301-52) / 50 mL in 1 TUBE 2 tube 2024-05-01 No No Current