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 29 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INNISFREE DAILY UV INVISIBLE BARRIER SUNSCREEN SERUM AVOBENZONE, HOMOSALATE, AND OCTISALATE Innisfree Corporation 524264b8-d360-1d7b-e063-6394a90ab115 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST12 KOKKINI) ZINC OXIDE Ilia, Inc. b595bcc6-a1ab-25c9-e053-2995a90a87aa 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST11.5 MORGAT) ZINC OXIDE Ilia, Inc. b97f7fe9-c070-7c11-e053-2a95a90a6a6d 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST0.5 SKYE) ZINC OXIDE Ilia, Inc. b959e3c3-ca92-ee41-e053-2a95a90a6064 2026-05-21 Warnings Exact identifier application number: M020 ILIA SUPER SERUM SKIN TINT (ST17 MIHO) ZINC OXIDE Ilia, Inc. b595f875-b774-f847-e053-2995a90a2886 2026-05-21 Warnings Exact identifier application number: M020 LBEL FOREVER MATTE SHINE CONTROL AND 90H HYDRATION FOUNDATION SPF 15 CREME 110C OCTINOXATE, ZINC OXIDE BEL STAR S.A. 526a8e50-b1de-47e5-e063-6394a90a3a29 2026-05-21 Warnings Exact identifier application number: M020 Live Tinted Hueguard Skin Tint ZINC OXIDE Live Tinted 0ff39ab1-e8d3-cad9-e063-6394a90af0eb 2026-05-21 Warnings Exact identifier application number: M020 Sunsolve MD Mineral Shade Quartz 001 ZINC OXIDE Sunsolve MD Inc 26a54f00-d84d-8fe3-e063-6394a90a03e8 2026-05-21 Warnings Exact identifier application number: M020 Inde Wild ZINC OXIDE Inde Wild 01529c59-8806-6423-e063-6294a90a49e3 2026-05-21 Warnings Exact identifier application number: M020 CARDON SPF and MOISTURIZER AVOBENZONE, HOMOSALATE, OCTYL SALICYLATE Cardon, Inc 52122434-6e6f-39fc-e063-6394a90a1fd0 2026-05-21 Warnings Exact identifier application number: M020 Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45 OCTINOXATE AND ZINC OXIDE Merz North America, Inc 62c822d9-c8ed-4b95-8d88-806295f5a936 2026-05-20 Warnings Exact identifier application number: M020 SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50 TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc 0b92a940-0dd4-4266-bd47-88c27def62c0 2026-05-20 Warnings Exact identifier application number: M020 Stream2Sea SPF 50 ZINC OXIDE Stream2Sea 5243f110-fe5b-946a-e063-6394a90add7e 2026-05-20 Warnings Exact identifier application number: M020 SP-FB0D-L0TNBarrierProtectionMineralSunscreen BARRIER PROTECTION MINERAL SUNSCREEN Epic Etailers, LLC (DBA: Beauty by Earth) 50786950-1c31-e467-e063-6394a90a6fc8 2026-05-20 Warnings Exact identifier application number: M020 IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50 TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc. fded7dfb-ffb9-4fb0-9511-273e0e126969 2026-05-20 Warnings Exact identifier application number: M020 Freaks of Nature Peak Performance Broad Spectrum SPF 50 FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50 THE FREAKS OF NATURE, INC. 5247187d-a14c-6468-e063-6394a90ace3e 2026-05-20 Warnings Exact identifier application number: M020 Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 OCTINOXATE AND ZINC OXIDE Merz North America, Inc. e120a659-0dfc-42ca-8158-58e8a0b457e5 2026-05-20 Warnings Exact identifier application number: M020 Evereden Cooling Mineral Sunstick SPF 30 ZINC OXIDE Eden Brands Inc. 4af9e668-0d88-74ad-e063-6394a90a5243 2026-05-19 Warnings Exact identifier application number: M020 Freaks of Nature Peak Performance Broad Spectrum SPF 30 FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30 THE FREAKS OF NATURE, INC. 522addd5-9701-3234-e063-6294a90aaa9d 2026-05-19 Warnings Exact identifier application number: M020 Freaks of Nature Peak Performance Broad Spectrum SPF 30 FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 30 THE FREAKS OF NATURE, INC. 522b4aca-fe5b-dfe2-e063-6394a90ae578 2026-05-19 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