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 249 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RV Illuminance Serum Tint Broad Spectrum 15 Rich Sand FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 2a0b6ba3-b5da-f2f7-e063-6394a90a86ae 2024-12-24 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 Soft Nutmeg FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 2a0b856a-d714-892c-e063-6294a90a4ae9 2024-12-24 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 Sandalwood FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 2a0b856a-d712-892c-e063-6294a90a4ae9 2024-12-24 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 Tan Sand FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 2a0b5cca-4e4f-efb6-e063-6294a90a6206 2024-12-24 Warnings Exact identifier application number: M020 RV Illuminance Serum Tint Broad Spectrum 15 Warm Caramel FACE FOUNDATION WITH SPF REVLON CONSUMER PR Consumer Products Corp 2a0b9147-3c7a-d549-e063-6394a90a6869 2024-12-24 Warnings Exact identifier application number: M020 Nu Skin 180 Degree UV Defense Hydrator SPF 18 OCTINOXATE AND ZINC OXIDE NSE Products, Inc 91a22a5a-87fd-4db0-9183-caebee401304 2024-12-24 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc aefd7884-6bc3-4b0b-ba36-1f3e8fe49f93 2024-12-23 Warnings Exact identifier application number: M020 Attitude mineral sunscreen tropical SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 56e57ca0-d163-4580-9bca-747acce4d69f 2024-12-23 Warnings Exact identifier application number: M020 (S)UNDERCOVER SPF 50 ZINC OXIDE TUBBY TODD dca478a0-c319-68d8-e053-2a95a90a10fc 2024-12-23 Warnings Exact identifier application number: M020 LOreal Paris Revitalift Triple Power Anti Aging Moisturizer Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc e7bef1da-ea35-4306-b043-73d566a7e6bb 2024-12-23 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 46aa9917-52ac-4c57-afde-366d2d3ca200 2024-12-23 Warnings Exact identifier application number: M020 La Roche Posay Anthelios UV Clear Daily Invisible Broad Spectrum SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 1d115945-fa1b-485b-bf53-44308fd1a630 2024-12-23 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 Sunscreen OCTINOXATE L'Oreal USA Products Inc 7cc920de-c91f-4040-a0b9-ea216d6f9bd7 2024-12-23 Warnings Exact identifier application number: M020 Kids SPF50Plus Mineral Sunscreen Rollerball Totally Tropical ZINC OXIDE AND TITANIUM DIOXIDE KAS Direct LLC dba BabyGanics d3bdda65-bcb4-42d9-84af-d14c7f4421bd 2024-12-23 Warnings Exact identifier application number: M020 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE LOreal USA Products Inc e8539a43-db85-451c-bce8-2c488f3dc40d 2024-12-23 Warnings Exact identifier application number: M020 NYX Professional Makeup Buttermelt Glaze SOFT GLOW SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30 HOMOSALATE,OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc 81093d80-dcaf-4555-98b2-48ce7eb84d0c 2024-12-23 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 Sunscreen OCTINOXATE SICOS ET CIE c634eaab-f014-4155-a40b-9030e358ec12 2024-12-23 Warnings Exact identifier application number: M020 Kids SPF50 Plus Mineral Sunscreen Continuous Totally Tropical ZINC OXIDE AND TITANIUM DIOXIDE KAS Direct LLC dba BabyGanics d5ffe993-de8f-4623-a010-9cb8dd70de07 2024-12-23 Warnings Exact identifier application number: M020 CERAVE Hydrating Mineral Sunscreen Light Sheer Tint Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE LOreal USA Products Inc 8b298516-70df-47ab-834f-51dcde28a43a 2024-12-23 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 27 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE SICOS ET CIE 6a14ee23-28c9-4704-8af9-d1c4db0d9256 2024-12-23 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