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 188 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6 ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDE Hangzhou Jingshen Trading Co., Ltd. 3e069cb2-c4c5-abf5-e063-6394a90a56b0 2025-09-06 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 2C Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 761ce50c-2bf5-4ed0-91ac-9c47f8790ddb 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 3W Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 2781b921-eb0d-4270-addf-47301577b28c 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 5N Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 893434a1-72b8-4f0f-bfaa-2c9d775d7e27 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 7N Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 199d97a2-d32b-45ab-a43d-30522b0ca596 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 10N Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 638eafb5-08a8-425f-893f-d6609b868e2b 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 9C Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 41fd80a9-2c6f-4f3e-a37d-e781965ddc55 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 11W Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 50bac9fb-5b81-4cdd-9eae-ec9530fc46c3 2025-09-05 Warnings Exact identifier application number: M020 Jack Black L.L.C. AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM Jack Black L.L.C. 3e0eb291-6bda-2f26-e063-6294a90ac466 2025-09-05 Warnings Exact identifier application number: M020 Jack Black AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM Jack Black L.L.C. 3d5fafb9-62c9-ec69-e063-6394a90af8b9 2025-09-05 Warnings Exact identifier application number: M020 Jack Black AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM Jack Black L.L.C. 3e0f655e-6100-f1dd-e063-6394a90af7b7 2025-09-05 Warnings Exact identifier application number: M020 Truskin SPF 30 Mineral Sunscreen Facial Serum ZINC OXIDE Allure Labs 3e13299f-8d5d-373b-e063-6394a90ab256 2025-09-05 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 08b52f29-c1a0-c673-e063-6294a90a9a7a 2025-09-05 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 08b8003f-40be-3380-e063-6294a90a4f6b 2025-09-05 Warnings Exact identifier application number: M020 MAYDAY Everyday Sunscreen SPF 30 ZINC OXIDE Omniche Consumer Products Co. 3f53fb40-6347-46b0-979c-3522d9948198 2025-09-04 Warnings Exact identifier application number: M020 PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1 ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDE Hangzhou Jingshen Trading Co., Ltd. 18130858-429c-4ed4-a75b-5bc014481250 2025-09-04 Warnings Exact identifier application number: M020 Introstem PrismaStem Face Shield Cream OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. dd91374a-e3fc-42f1-a660-86b32a0cc8b8 2025-09-04 Warnings Exact identifier application number: M020 MEDICUBE COLLAGEN GLOW SUNSCREEN HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE APR US INC 34fae072-536c-ad41-e063-6394a90af0af 2025-09-03 Warnings Exact identifier application number: M020 Basin Sugar Plum SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3de75cec-955e-4b3a-e063-6394a90a1543 2025-09-03 Warnings Exact identifier application number: M020 Basin Mint SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Retail Concepts of Minnesota, Inc. 3de7d21b-4f88-d80c-e063-6394a90a8e4c 2025-09-03 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