Home NDC 84616-007 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM
Product NDC 84616-007
11-digit product format 846160007
Labeler code 84616
Product ID 84616-007_4fea1efd-c18a-817f-e063-6294a90a8afb
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate
Dosage form CREAM
Route TOPICAL
Labeler SEORIN COMPANY Co., Ltd.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-18
Substance HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength 13.5; 4.5; 2.7 g/100mL; g/100mL; g/100mL
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 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 13.5 g/100mL OCTISALATE 4.5 g/100mL AVOBENZONE 2.7 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84616-007-01 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 50 mL in 1 TUBE CREAM 50 5 84616-007-02 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 10 mL in 1 TUBE CREAM 10 5 84616-007-03 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 2 in 1 BOX CREAM 2 5 84616-007-04 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 60 mL in 1 TUBE CREAM 60 5 84616-007-05 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 30 mL in 1 TUBE CREAM 30 5
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 123 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Untinted Sheer Defense TITANIUM DIOXIDE, ZINC OXIDE Kristina Lerner 35be50b7-a9af-29ee-e063-6394a90a45ba 2025-12-15 Exact identifier application number: M020 Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE VIDA HEALTH & WELLNESS LLC 3724ea3c-b018-c125-e063-6394a90a01f1 2025-12-15 Exact identifier application number: M020 Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE VIDA HEALTH & WELLNESS LLC 37252429-d692-c05a-e063-6294a90a6af6 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen ZINC OXIDE Bodi & Wax, LLC 35d2fbeb-935b-f0a9-e063-6294a90acd79 2025-12-15 Exact identifier application number: M020 BHSkin Sheer Tinted Zinc and Titanium SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Don Mehrabi, M.D. A Professional Medical Corporation 423c7e62-ad50-0dc3-e063-6294a90ad05a 2025-12-15 Warnings Exact identifier application number: M020 Tined Mineral Sunscreen Whipped Mousse TITANIUM DIOXIDE, ZINC OXIDE ESTILO SALON & SPA LLC 3699c107-d063-cc6f-e063-6394a90a6ad4 2025-12-15 Exact identifier application number: M020 BHSkin Sheer Tinted Zinc and Titanium SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Don Mehrabi, M.D. A Professional Medical Corporation 44776529-3aa6-4fa3-b2ce-f624c4cf41bd 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE JMSE Management, LLC 36ec860f-2066-196c-e063-6294a90a2121 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen ZINC OXIDE Bodi & Wax, LLC 35d3262a-1d8d-2afa-e063-6294a90afd49 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen Non-Tinted ZINC OXIDE Bodi & Wax, LLC 35d37c2e-abc0-6bda-e063-6294a90a8fc3 2025-12-15 Exact identifier application number: M020 Tined Mineral Sunscreen Whipped Mousse TITANIUM DIOXIDE, ZINC OXIDE ESTILO SALON & SPA LLC 36999510-88f0-64fc-e063-6294a90a3d09 2025-12-15 Exact identifier application number: M020 Parasol Daily Mineral Sunscreen Non-Tinted ZINC OXIDE Bodi & Wax, LLC 35d3486c-c6e8-4d31-e063-6294a90a1219 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Cream ZINC OXIDE ESTILO SALON & SPA LLC 3699f6df-63b8-f255-e063-6394a90af2c4 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Cream ZINC OXIDE ESTILO SALON & SPA LLC 369a5997-7dbe-254d-e063-6394a90a5bef 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE ESTILO SALON & SPA LLC 369a8a99-c755-3c7f-e063-6394a90ac16c 2025-12-15 Exact identifier application number: M020 Non Tinted Mineral Sunscreen 20Percent Zinc Oxide ZINC OXIDE ESTILO SALON & SPA LLC 369abc9d-9c20-5397-e063-6394a90a1723 2025-12-15 Exact identifier application number: M020 Sunshade Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37dec631-fdaf-fbdf-e063-6394a90a6c2b 2025-12-15 Exact identifier application number: M020 Matte Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE EDIT EUROSPA, LLC 37527317-0f10-d7e6-e063-6394a90a35a6 2025-12-15 Exact identifier application number: M020 Sunshade Mineral Stick Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37ee31be-bfda-f052-e063-6294a90ac0bb 2025-12-15 Exact identifier application number: M020 Matte Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE EDIT EUROSPA, LLC 3751544d-e093-3d19-e063-6394a90aefc3 2025-12-15 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84616-007-01 84616000701 50 mL in 1 TUBE (84616-007-01) 50 ml 2024-09-18 No No Current 84616-007-02 84616000702 10 mL in 1 TUBE (84616-007-02) 10 ml 2024-12-18 No No Current 84616-007-03 84616000703 2 TUBE in 1 BOX (84616-007-03) / 60 mL in 1 TUBE (84616-007-04) 2 tube 2024-12-20 No No Current 84616-007-04 84616000704 60 mL in 1 TUBE 60 ml Historical 84616-007-05 84616000705 30 mL in 1 TUBE (84616-007-05) 30 ml 2026-04-20 No No Current