Home NDC 65435-0400 Safe Sea SPF 50 Mineral
Product NDC 65435-0400
11-digit product format 654350400
Labeler code 65435
Product ID 65435-0400_44573470-8de8-ad1d-e063-6294a90a7a4a
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Nidaria Technology Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-20
Substance ZINC OXIDE
Active strength 210 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Mineral
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 210 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
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 65435-0400-1 Safe Sea SPF 50 Mineral 60 mL in 1 TUBE LOTION 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65435-0400 SAFE SEA SPF 50 MINERAL (ZINC OXIDE) LOTION [NIDARIA TECHNOLOGY LTD.] 2 Current NDC, 1 package rows 20241123_f6cf9454-552b-486e-a38b-ab3c183b24a1.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 65435-0400-1 65435040001 60 mL in 1 TUBE (65435-0400-1) 60 ml 2023-06-20 No No Current