Home NDC 85638-004 Ocean Potion Suncare Mineral 30 Zinc Oxide Sunscreen
Product NDC 85638-004
11-digit product format 856380004
Labeler code 85638
Product ID 85638-004_3c6e7e6c-6bba-d88f-e063-6394a90afb5f
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler GNL BRANDS INTERNATIONAL, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-14
Substance ZINC OXIDE
Active strength 206 mg/mL
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 Ocean Potion Suncare Mineral 30 Zinc Oxide Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 206 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85638-004-66 Ocean Potion Suncare Mineral 30 Zinc Oxide Sunscreen 100 mL in 1 TUBE LOTION 100 1
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 85638-004-66 85638000466 100 mL in 1 TUBE (85638-004-66) 100 ml 2025-02-14 No No Current