Home NDC 84616-005 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM
Product NDC 84616-005
11-digit product format 846160005
Labeler code 84616
Product ID 84616-005_4260e398-1153-07e9-e063-6394a90ac3be
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 2026-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 84616-005-03 excluded package package 84616-005-01 excluded package package 84616-005-02
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 SPF45 BROAD SPECTRUM
Listing expiration 2026-12-31 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 84616-005-01 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM 50 mL in 1 TUBE CREAM 50 1 84616-005-02 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM 10 mL in 1 TUBE CREAM 10 1 84616-005-03 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM 2 in 1 BOX CREAM 2 1 84616-005-04 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM 60 mL in 1 TUBE CREAM 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84616-005 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SEORIN COMPANY CO., LTD.] 3 Current NDC 20250418_228dcd68-aaba-0451-e063-6394a90a8ad0.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 156 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OUHOE Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 42fcc9ed-083c-6582-e063-6394a90ae9e6 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Sun Cream TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305cb87e-450f-840a-e063-6294a90a883f 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Bio Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 349a3d72-9969-855d-e063-6394a90a281c 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Cica Cooling Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 305c13af-0843-f478-e063-6394a90a42de 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Quick Sun Stick Protection Bar TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 3578c958-a457-402b-e063-6394a90a7342 2025-11-27 Warnings Exact identifier application number: M020 EELHOE Matte Sun Stick TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 42cfa690-15fe-e5de-e063-6394a90a8e71 2025-11-27 Warnings Exact identifier application number: M020 JAYSUING Moisturiser Sun Stick TITANIUM DIOXIDE Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. 42c307d9-aaa9-30df-e063-6294a90aa114 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4494bea6-ab1f-aae6-e063-6394a90a184d 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Baby Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44853202-6873-0bc8-e063-6394a90a05f0 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 43f43c5a-2680-f549-e063-6394a90aade3 2025-11-27 Warnings Exact identifier application number: M020 Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE THG Beauty USA LLC 44952d01-7f38-0a9c-e063-6394a90a2018 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Tropical coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44954d7c-2a78-3df4-e063-6294a90ab56f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick SPF 50 Watermelon and Coco ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 449712ab-5c23-7d50-e063-6394a90ab7fe 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick SPF 50 Sun kissed vanilla ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44991f67-9160-ccce-e063-6394a90ada1f 2025-11-27 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Sprayer SPF 50 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 4499bcda-f0ba-878e-e063-6394a90a5fc0 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc Kids Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44615ae4-8206-122d-e063-6294a90a0b2c 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 42fd5d3e-4e98-86d7-e063-6294a90a45c2 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Sunscreen TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375b60f1-ad33-578a-e063-6294a90a1fc6 2025-11-27 Warnings Exact identifier application number: M020 EcoZinc x DSO Welders 98 percent UVC Protection Sunscreen for Welding ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386e35de-cd13-f430-e063-6394a90acc84 2025-11-27 Warnings Exact identifier application number: M020 HANCHOBIT Matte Sun Stick TITANIUM DIOXIDE HANCHOYEANBIOTEC Co.,Ltd. 375bacf7-9372-bff7-e063-6294a90ae67c 2025-11-27 Warnings 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 84616-005-01 84616000501 50 mL in 1 TUBE (84616-005-01) 50 ml 2024-09-18 No No Current 84616-005-02 84616000502 10 mL in 1 TUBE (84616-005-02) 10 ml 2024-12-18 No No Current 84616-005-03 84616000503 2 TUBE in 1 BOX (84616-005-03) / 60 mL in 1 TUBE (84616-005-04) 2 tube 2024-12-20 No No Current 84616-005-04 84616000504 60 mL in 1 TUBE 60 ml Historical