Home NDC 65435-0200 Safe Sea SPF 50 kids
Product NDC 65435-0200
11-digit product format 654350200
Labeler code 65435
Product ID 65435-0200_4584a0f3-ef34-c289-e063-6294a90ad706
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Octocrylene, Octisalate, Avobenzone
Dosage form LOTION
Route TOPICAL
Labeler NIDARIA TECHNOLOGY LTD
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-04-30
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 50 kids
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 65435-0200-1 Safe Sea SPF 50 kids 118 mL in 1 BOTTLE LOTION 118 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65435-0200 SAFE SEA SPF 50 KIDS (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) LOTION [NIDARIA TECHNOLOGY LTD] 7 Current NDC, Legacy NDC, 1 package rows 20241123_3fa04557-2bc1-4eb4-aed8-eacc79189613.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 65435-0200-1 65435020001 118 mL in 1 BOTTLE (65435-0200-1) 118 ml 2021-04-30 0000-00-00 No No Current 65435-0200-2 65435020002 100 mL in 1 TUBE (65435-0200-2) 100 ml 2021-11-05 0000-00-00 No No Current