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 208 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel OCTINOXATE, ZINC OXIDE BEL STAR S A c4f95c1b-acbe-4bb7-e053-2995a90a9120 2025-06-19 Warnings Exact identifier application number: M020 LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-N OCTINOXATE, ZINC OXIDE Bel Star S.A. d22fde8a-ba14-2cc7-e053-2a95a90a0e53 2025-06-19 Warnings Exact identifier application number: M020 Correct and Protect Serum Broad Spectrum SPF 45 ZINC OXIDE Murad, LLC dba6e01b-a8ec-4812-bbe0-e418bb067032 2025-06-19 Warnings Exact identifier application number: M020 Truffoire Truffle Brightening OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. e3068ecf-0bee-4e8a-a439-4bb707a2845d 2025-06-18 Warnings Exact identifier application number: M020 Aveeno Kids Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 383de98b-65b5-4398-a876-87367dc01d0b 2025-06-18 Warnings Exact identifier application number: M020 CB Multi-Active Moisturizer with SPF 30 OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. d9557a6c-78e9-4b01-8a4b-e0eceb511c4e 2025-06-18 Warnings Exact identifier application number: M020 1000 Roses CC Color plus Correct Sheer Beige SPF 30 ZINC OXIDE Andalou naturals 2e7f3570-f710-41dd-95a0-7c0613b317a2 2025-06-17 Warnings Exact identifier application number: M020 Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30 TITANIUM DIOXIDE, ZINC OXIDE SKIN CARE BY SCOTTIE LLC a9afa58c-f438-48c6-bd30-eda41334df74 2025-06-16 Warnings Exact identifier application number: M020 Wellage Real Hyaluronic Watery Glow Sun Screen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Hugel, Inc. 37aa2f7b-afa4-5cc9-e063-6294a90ae741 2025-06-16 Warnings Exact identifier application number: M020 Dermaka Sunscreen SPF 42, Tinted TITANIUM DIOXIDE, ZINC OXIDE DERMAKA SKIN PRODUCTS 9a967cd1-9eec-4255-b14b-ac2e33e4dbf0 2025-06-16 Warnings Exact identifier application number: M020 Elizabeth Arden Eight Hour Hydraplay SPF 40 OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE Revlon Consumer Products Corp 2cc74177-0f62-106e-e063-6394a90a6e28 2025-06-16 Warnings Exact identifier application number: M020 BALI BODY SPF15 BRONZE SHIMMERING TANNING AVOBENZONE, OCTISALATE, OCTOCRYLENE Bali Body Pty Ltd 240d4d80-641c-ac57-e063-6394a90abe75 2025-06-16 Warnings Exact identifier application number: M020 Environ Skin Care RAD Shield Mineral Sunscreen SPF 30 SUNSCREEN ENVIRON SKIN CARE (PTY) LTD 3778547e-11a8-3b30-e063-6394a90ab5b1 2025-06-13 Warnings Exact identifier application number: M020 Voupre Age Defense OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 8dfaa076-c62a-47ee-bc5d-75360416fa1a 2025-06-13 Warnings Exact identifier application number: M020 Instantly Dry TITANIUM DIOXIDE, ZINC OXIDE CLEAN BEAUTY BY ANAK LLC 37624bf6-4949-1b10-e063-6294a90ac488 2025-06-12 Exact identifier application number: M020 silk SPF facial sunscreen fluid hybrid broad spectrum SPF 30 UVA/UVB ZINC OXIDE AND HOMOSALATE OneKind.25 d739bc43-d76e-9258-e053-2a95a90a3d2c 2025-06-12 Warnings Exact identifier application number: M020 ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 HOMOSALATE, OCTISALATE, AND AVOBENZONE Andalou naturals 0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f 2025-06-11 Warnings Exact identifier application number: M020 Hydrating Sheer Lip Balm Trio The Vivids Broad Spectrum SPF 30 AVOBENZONE, OCTISALATE, AND HOMOSALATE MDSolarSciences 374e770f-75b5-08d0-e063-6394a90adf92 2025-06-11 Warnings Exact identifier application number: M020 Reflecting Mineral Sunscreen ZINC OXIDE, TITANIUM DIOXIDE Helande, LLC 3750f04b-7f9f-8793-e063-6294a90a9143 2025-06-11 Warnings Exact identifier application number: M020 Vitamin C BB Beauty Balm Sheer Tint SFP 30 ZINC OXIDE Andalou naturals f423b484-2119-4c95-a0da-77bcd07303eb 2025-06-11 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