Home NDC 84509-002 Sunscreen Emulsion SPF50plus
Product NDC 84509-002
11-digit product format 845090002
Labeler code 84509
Product ID 84509-002_2b3ecbec-979d-d07c-e063-6294a90a717a
Type HUMAN OTC DRUG
Nonproprietary name Octocrylene,Ethylhexyl Methoxycirnnamate,Titanium Dioxide,Ethylhexyl Salicylate
Dosage form LOTION
Route TOPICAL
Labeler Guangzhou Senmai Biotechnology Co.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-16
Substance OCTISALATE; OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE
Active strength 1500; 3000; 3000; 2400 mg/30mL; mg/30mL; mg/30mL; mg/30mL
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 Sunscreen Emulsion SPF50plus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 1500 mg/30mL OCTOCRYLENE 3000 mg/30mL OCTINOXATE 3000 mg/30mL TITANIUM DIOXIDE 2400 mg/30mL
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 84509-002-01 Sunscreen Emulsion SPF50plus 30 mL in 1 BOTTLE LOTION 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84509-002 SUNSCREEN EMULSION SPF50PLUS (OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE) LOTION [GUANGZHOU SENMAI BIOTECHNOLOGY CO.] 3 Current NDC, 1 package rows 20250110_1d560670-026b-bd34-e063-6394a90a9af4.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 84509-002-01 84509000201 30 mL in 1 BOTTLE (84509-002-01) 30 ml 2024-07-16 No No Current