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 165 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspen Islanders Sheer Mineral Sport ZINC OXIDE Aspen Islanders LLC 0fcb2adf-71c9-3369-e063-6294a90aa806 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE MALON DAZE By the Beach Suncare LLC 4391728b-dfe7-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CITRUS CRUSH By the Beach Suncare LLC 43918d25-e947-5e17-e063-6394a90ada7c 2025-11-14 Warnings Exact identifier application number: M020 By the Beach Suncare SPF 30 SUNCARE CANDY CLOUDS By the Beach Suncare LLC 4391728b-dfe8-3ffb-e063-6394a90a240e 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Balance and Clear ZINC OXIDE Sunsolve MD Inc 26f3595d-adef-a8a5-e063-6394a90adfd4 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Detox and Shield ZINC OXIDE Sunsolve MD Inc 26f3886b-a3a5-c9b7-e063-6394a90af6c3 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Amber 002 ZINC OXIDE Sunsolve MD Inc 26e00001-9c68-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Agate 003 ZINC OXIDE Sunsolve MD Inc 26e00001-9c6f-0734-e063-6394a90a1787 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Bronzite 004 ZINC OXIDE Sunsolve MD Inc 26e13356-9ab5-246a-e063-6394a90a2a70 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Onyx 006 ZINC OXIDE Sunsolve MD Inc 26e16b5e-dd2e-6fb8-e063-6394a90a6a7f 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Calm and Revitalize ZINC OXIDE Sunsolve MD Inc 26f3f534-a305-3530-e063-6394a90a75e1 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Garnet 005 ZINC OXIDE Sunsolve MD Inc 26e1508f-d386-329b-e063-6394a90a0a98 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Firm and Replenish ZINC OXIDE Sunsolve MD Inc 26f3417b-9ea4-e577-e063-6294a90ae53c 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Correct and Fade ZINC OXIDE Sunsolve MD Inc 26f3ad9f-f8ca-05d4-e063-6394a90ad5c4 2025-11-14 Warnings Exact identifier application number: M020 Sunsolve MD Volumize and Condition Lip ZINC OXIDE Sunsolve MD 396b7462-d597-4bf7-e063-6394a90ab58d 2025-11-14 Warnings Exact identifier application number: M020 Sunsovle MD Volumize and Restore ZINC OXIDE Sunsolve MD Inc 26f3cdda-b990-15cb-e063-6394a90ade29 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew-Glow Moisturizer SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc 0a5b80fb-caeb-eb56-e063-6294a90a238b 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew Glow Tinted Moisturizer SPF50 HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc. 0d82f310-f87a-f76d-e063-6294a90af251 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew Glow Tinted Moisturizer SPF50-deep HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc. 0d865e74-1baf-6a44-e063-6394a90a37ac 2025-11-14 Warnings Exact identifier application number: M020 Naturium Dew Glow Tinted Moisturizer SPF50-medium HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f. Cosmetics, Inc. 0d8616a8-2eab-c85c-e063-6294a90a3984 2025-11-14 Warnings Exact identifier application number: M020
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