Home NDC 84164-461 TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance Free
Product NDC 84164-461
11-digit product format 841640461
Labeler code 84164
Product ID 84164-461_12fad27d-d6ff-6872-e063-6294a90a9586
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler 6174 INDUSTRIES, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-04
Substance HOMOSALATE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength 100; 50; 50; 40 mg/mL; mg/mL; mg/mL; mg/mL
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 TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance Free
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 50 mg/mL ZINC OXIDE 40 mg/mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84164-461-00 TROPICAL OTTERS Glitter Sunscreen SPF-50 - Fragrance Free 133 mL in 1 TUBE CREAM 133 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84164-461 TROPICAL OTTERS GLITTER SUNSCREEN SPF-50 - FRAGRANCE FREE (HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE) CREAM [6174 INDUSTRIES, LLC] 1 Current NDC, 1 package rows 20240307_658b1b20-6540-4f3a-ac9a-170bc8fcba11.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 84164-461-00 84164046100 133 mL in 1 TUBE (84164-461-00) 133 ml 2024-03-04 No No Current