Home NDC 65435-0600 Safe Sea SPF 30
Product NDC 65435-0600
11-digit product format 654350600
Labeler code 65435
Product ID 65435-0600_445736eb-4083-8204-e063-6394a90a6024
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 2025-02-01
Substance ZINC OXIDE
Active strength 10.9 g/100g
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 30
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 10.9 g/100g
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 65435-0600-1 Safe Sea SPF 30 100 g in 1 TUBE LOTION 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65435-0600 SAFE SEA SPF 30 (ZINC OXIDE) LOTION [NIDARIA TECHNOLOGY LTD.] 2 Current NDC, 1 package rows 20250201_91bf07ed-0be4-43c9-b5f3-4e8eb892bca5.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 65435-0600-1 65435060001 100 g in 1 TUBE (65435-0600-1) 100 g 2025-02-01 No No Current