Home NDC 52854-515 Reef Babies SPF 50 Oxybenzone Free
Product NDC 52854-515
11-digit product format 528540515
Labeler code 52854
Product ID 52854-515_42c9f018-98d9-575f-e063-6394a90a2566
Type HUMAN OTC DRUG
Nonproprietary name octocrylene, octisalate, and avobenzone
Dosage form LOTION
Route TOPICAL
Labeler Tropical Seas, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-05-01
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 52854-515-01 Reef Babies SPF 50 Oxybenzone Free 120 mL in 1 BOTTLE, PLASTIC LOTION 120 8 52854-515-02 Reef Babies SPF 50 Oxybenzone Free 192 mL in 1 BOTTLE, PLASTIC LOTION 192 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52854-515 REEF BABIES SPF 50 OXYBENZONE FREE (OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [TROPICAL SEAS, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20241103_8cd68b09-2578-4519-b00e-e83e0e440815.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 52854-515-01 52854051501 120 mL in 1 BOTTLE, PLASTIC (52854-515-01) 120 ml 2017-05-01 0000-00-00 No No Current 52854-515-02 52854051502 192 mL in 1 BOTTLE, PLASTIC (52854-515-02) 192 ml 2022-11-14 0000-00-00 No No Current