Home NDC 85638-003 Ocean Potion Suncare 30 Continuous Sunscreen Scent of Sunshine
Product NDC 85638-003
11-digit product format 856380003
Labeler code 85638
Product ID 85638-003_3e60bd4f-c7d9-1c8b-e063-6394a90aeef8
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler GNL BRANDS INTERNATIONAL, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-30
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 30; 100; 20; 50 mg/g; mg/g; mg/g; mg/g
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 30 Continuous Sunscreen Scent of Sunshine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g HOMOSALATE 100 mg/g OCTOCRYLENE 20 mg/g OCTISALATE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
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 85638-003-37 Ocean Potion Suncare 30 Continuous Sunscreen Scent of Sunshine 156 g in 1 CAN SPRAY 156 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 242 of 353 · 7,041 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85638-003-37 85638000337 156 g in 1 CAN (85638-003-37) 156 g 2024-08-30 No No Current