Home NDC 85638-006 Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 Sunscreen
Product NDC 85638-006
11-digit product format 856380006
Labeler code 85638
Product ID 85638-006_3c6f3e1d-9cae-8fcf-e063-6394a90a8d60
Type HUMAN OTC DRUG
Nonproprietary name Octocrylene, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler GNL BRANDS INTERNATIONAL, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-17
Substance ZINC OXIDE; OCTOCRYLENE
Active strength 50.2125; 40 mg/mL; 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 Face with Clear Zinc Oxide Broad Spectrum SPF 50 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 50.2125 mg/mL OCTOCRYLENE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 5A68WGF6WM 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 85638-006-42 Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 Sunscreen 30 mL in 1 JAR LOTION 30 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 85638-006-42 85638000642 30 mL in 1 JAR (85638-006-42) 30 ml 2024-12-17 No No Current