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 260 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BIO SPECTRA ATTITUDE ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 06245c8c-93e8-4ebb-bab0-3db64dc178b9 2024-12-09 Warnings Exact identifier application number: M020 BANANA BOAT KIDS SPF 65 CLEAR SUNSCREEN AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC dc7b0d17-d7c8-433f-e053-2995a90a477d 2024-12-09 Warnings Exact identifier application number: M020 Sheer Zinc SPF 30 ZINC OXIDE Allure Labs b6b45dac-41d0-1b55-e053-2a95a90acf61 2024-12-09 Warnings Exact identifier application number: M020 Broad Spectrum SPF30 Mineral Sunscreen ZINC OXIDE Allure Labs dafc8e62-7c99-1f6d-e053-2995a90a7791 2024-12-09 Warnings Exact identifier application number: M020 Prevention Daily Tinted Moisturizer SPF 30 ZINC OXIDE AND TITANIUM DIOXIDE Allure Labs ed883d63-777c-e924-e053-2995a90a162a 2024-12-09 Warnings Exact identifier application number: M020 I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen Mahogany ZINC OXIDE AND TITANIUM DIOXIDE Allure Labs dcba05ff-7a68-c5c0-e053-2a95a90a6129 2024-12-09 Warnings Exact identifier application number: M020 Prevention Daily Matte Moisturizer SPF 30 ZINC OXIDE AND HOMOSALATE Allure Labs f0fb1b69-53f2-efff-e053-2995a90af9d4 2024-12-09 Warnings Exact identifier application number: M020 MD Restoring daily Defense Moisturizer SPF 50 ZINC OXIDE AND TITANIUM DIOXIDE Allure Labs Inc eb8e7109-b5eb-5cc1-e053-2995a90a486f 2024-12-09 Warnings Exact identifier application number: M020 Prevention Sun Serum SPF 30 Tinted ZINC OXIDE Allure Labs f1761b09-9061-a052-e053-2a95a90a39c8 2024-12-09 Warnings Exact identifier application number: M020 Prevention Sun Serum SPF30 ZINC OXIDE Allure Labs f188669f-7b9f-6e01-e053-2995a90afa3c 2024-12-09 Warnings Exact identifier application number: M020 Prevention Clear Solar Gel SPF30 AVOBENZON, OCTISALATE AND OCTOCRYLENE Allure LAbs f19f6d9b-5249-27a6-e053-2a95a90a8a39 2024-12-09 Warnings Exact identifier application number: M020 OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Tinted ZINC OXIDE Allure Labs 02e7fb00-2039-c4f8-e063-6294a90a418f 2024-12-09 Warnings Exact identifier application number: M020 OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen Untinted ZINC OXIDE Allure Labs 02f9c859-8d7d-5146-e063-6394a90a57b5 2024-12-09 Warnings Exact identifier application number: M020 Quench and Protect Hydrating SPF30 ZINC DIOXIDE AND TITANIUM DIOXIDE Allure Labs. 039e50c1-7b3d-d392-e063-6394a90a4b3c 2024-12-09 Warnings Exact identifier application number: M020 Tinted Face Cream SPF 15 OCTOCRYLENE, OCTISALATE Bentley Laboratories, LLC 0d7300ee-adf4-41be-bb9f-257cd2986c0f 2024-12-06 Warnings Exact identifier application number: M020 Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50 TITANIUM DIOXIDE, ZINC OXIDE Beautcella Inc. bad942d8-04da-31d2-e053-2a95a90a9275 2024-12-06 Warnings Exact identifier application number: M020 TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE TOM FORD BEAUTY DIST 289b824f-bb0b-313e-e063-6394a90ab783 2024-12-06 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d840001-a648-df1b-e063-6294a90ab299 2024-12-06 Warnings Exact identifier application number: M020 Performance Face Sunscreen Broad Spectrum SPF 30 ZINC OXIDE, OCTOCRYLENE, OCTISALATE Bentley Laboratories, LLC 1629f061-b8fc-4fda-8378-c64e164d41bd 2024-12-06 Warnings Exact identifier application number: M020 Clear System Brightening Day Cream SPF 15 OCTOCRYLENE, OCTISALATE Bentley Laboratories, LLC 8cbc8fa4-469f-4fa3-bd8e-27e815989c3f 2024-12-06 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