Home NDC 65435-0300 Safe Sea SPF 40
Product NDC 65435-0300
11-digit product format 654350300
Labeler code 65435
Product ID 65435-0300_4584a34d-7130-aa5e-e063-6394a90ae4f2
Type HUMAN OTC DRUG
Nonproprietary name Octocrylene, Homosalate, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane
Dosage form LIQUID
Route TOPICAL
Labeler NIDARIA TECHNOLOGY LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-01
Substance OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength 100; 100; 50; 30 mg/mL; mg/mL; mg/mL; mg/mL
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 Safe Sea SPF 40
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 100 mg/mL HOMOSALATE 100 mg/mL OCTISALATE 50 mg/mL AVOBENZONE 30 mg/mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65435-0300-1 Safe Sea SPF 40 118 mL in 1 BOTTLE LIQUID 118 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65435-0300 SAFE SEA SPF 40 (OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE) LIQUID [NIDARIA TECHNOLOGY LTD] 8 Current NDC, Legacy NDC, 1 package rows 20241123_c900b88b-1de1-4df9-af84-d9001e1d4764.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 Marketing end Sample Exclude flag Status 65435-0300-1 65435030001 118 mL in 1 BOTTLE (65435-0300-1) 118 ml 2021-01-01 0000-00-00 No No Current