Home NDC 69630-004 Zinc Oxide 20%
Product NDC 69630-004
11-digit product format 696300004
Labeler code 69630
Product ID 69630-004_4db2b8a1-b627-9f7b-e063-6394a90a1fa9
Type HUMAN OTC DRUG
Nonproprietary name Sunscreen SPF 50
Dosage form LOTION
Route TOPICAL
Labeler The Soleil Group, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-09
Substance ZINC OXIDE
Active strength 20 g/100mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Zinc Oxide 20%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 g/100mL
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 69630-004-01 Zinc Oxide 20% 1 in 1 CARTON LOTION 1 2 69630-004-01 Zinc Oxide 20% 16 mL in 1 BOTTLE LOTION 16 2
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 69630-004-01 69630000401 1 BOTTLE in 1 CARTON (69630-004-01) / 16 mL in 1 BOTTLE 1 bottle 2025-12-01 No No Current