Home NDC 52854-558 Reef Babies SPF 50 Oxybenzone Free
Product NDC 52854-558
11-digit product format 528540558
Labeler code 52854
Product ID 52854-558_42ca59d6-ed3a-be73-e063-6394a90a8477
Type HUMAN OTC DRUG
Nonproprietary name octocrylene, octisalate, and avobenzone
Dosage form SPRAY
Route TOPICAL
Labeler Tropical Seas, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-07
Substance OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength 10; 5; 3 g/100mL; g/100mL; g/100mL
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 Reef Babies SPF 50 Oxybenzone Free
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 10 g/100mL OCTISALATE 5 g/100mL AVOBENZONE 3 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup 4X49Y0596W Internal UNII lookup G63QQF2NOX 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 52854-558-02 Reef Babies SPF 50 Oxybenzone Free 180 mL in 1 CAN SPRAY 180 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52854-558 REEF BABIES SPF 50 OXYBENZONE FREE (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [TROPICAL SEAS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20241103_d5ed3488-aa32-4a63-9996-12c6532c3a4d.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 Marketing end Sample Exclude flag Status 52854-558-02 52854055802 180 mL in 1 CAN (52854-558-02) 180 ml 2020-12-07 0000-00-00 No No Current