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 87 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Loretta Universal Glow Daily Defense SPF 40 ZINC OXIDE Dr. Loretta, LLC 1208d0f8-bb12-4574-b70e-3a76b11a64c7 2026-01-07 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face Sunscreen SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE KDC/One Development Corporation, Inc. 259f3fe3-2967-6c05-e063-6394a90a9e45 2026-01-07 Warnings Exact identifier application number: M020 Hawaiian Blend Extreme Zinc SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group 4084dd98-357f-4011-b0d4-db6536d2931f 2026-01-07 Warnings Exact identifier application number: M020 Hawaiian Blend Extreme Zinc SPF 50 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group 9b4acc5e-fdaf-4fcb-83a9-69e430dd43de 2026-01-07 Warnings Exact identifier application number: M020 Hawaiian Blend Sensitive Zinc SPF 50 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group b42261c5-fa6e-4bb3-93c0-97032ab9f716 2026-01-07 Warnings Exact identifier application number: M020 CabanaMilk Mineral Barrier Fluid SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 47d0fe4d-ad21-1004-e063-6394a90a9c19 2026-01-07 Warnings Exact identifier application number: M020 CENTELLA RELIEF SOOTHING SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE IUNIK Co., Ltd. 47d170e3-dd76-d413-e063-6294a90ae8e4 2026-01-07 Warnings Exact identifier application number: M020 Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum ZINC OXIDE SEORIN COMPANY Co., Ltd. 1e7cc417-3c57-c87c-e063-6394a90a670b 2026-01-07 Warnings Exact identifier application number: M020 Proactiv Clear Skin SPF 30 AVOBENZONE, OCTISALATE, AND OCTOCRYLENE Alchemee, LLC b0aa7ff0-f712-486f-aaaf-f88fed3b5cd1 2026-01-07 Warnings Exact identifier application number: M020 Daily Hydrating Mineral Body Sunscreen Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Oak Essentials, LLC 47d37f44-10b2-214f-e063-6294a90a5abc 2026-01-07 Warnings Exact identifier application number: M020 PLUMSCREEN SPF 31 ZINC OXIDE Le Prunier Farms, Inc. e20eb996-2b64-6bd0-e053-2a95a90a4f92 2026-01-07 Warnings Exact identifier application number: M020 BETA-GLUCAN MILD SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE IUNIK Co., Ltd 47d6ad8b-1081-ee21-e063-6294a90a0e63 2026-01-07 Warnings Exact identifier application number: M020 Koobarra Mineral Face Sunscreen SPF 50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 37cf8143-99f2-cca5-e063-6394a90a19a8 2026-01-07 Warnings Exact identifier application number: M020 Solar Swipe Mineral Sunscreen SPF50 SOLAR SWIPE MINERAL SUNSCREEN SPF50 Guangzhou Fantesy Biotechnology Co.,Ltd 47d75d61-5295-3eab-e063-6394a90a01c1 2026-01-07 Warnings Exact identifier application number: M020 LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREEN ZINC OXIDE JANE STREET LLC dbdd3e6a-f09d-90cf-e053-2a95a90a98a0 2026-01-07 Warnings Exact identifier application number: M020 RENEWALUXE SPF 50 Sunscreen RENEWALUXE SPF 50 SUNSCREEN Guangzhou Fantesy Biotechnology Co.,Ltd 1bc29960-5e73-e8ab-e063-6294a90a3f80 2026-01-06 Warnings Exact identifier application number: M020 ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN SPF50 Wild Child Laboratories PTY Ltd 2767ba3e-7434-d474-e063-6294a90aa4ff 2026-01-06 Warnings Exact identifier application number: M020 ULTRA VIOLETTE SPF ON THE GLOW Duo Pack Kit SPF 50 Grace And Fire USA Inc. 47b7da8a-ea89-1402-e063-6294a90a23f9 2026-01-06 Warnings Exact identifier application number: M020 Hawaiian Blend Essential Zinc SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group 5a6e622f-2c00-406a-8860-d7081656f597 2026-01-06 Warnings Exact identifier application number: M020 SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5 OCTINOXATE AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION 66c22f17-5418-42ff-97b2-33fa10f5eac3 2026-01-06 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