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 23 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Violette Preen Screen Broad Spectrum SPF 50 AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Grace and Fire USA Inc. 26a0fc0d-a903-2ac1-e063-6394a90a13db 2026-06-01 Warnings Exact identifier application number: M020 Timesavvy Hybrid XL Cushion Sun Serum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE ProBetter USA, Inc. 82a22071-f1bd-4fab-b929-8a00ef18f0d9 2026-05-31 Warnings Exact identifier application number: M020 Marine Screen Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE OSEA International, LLC 9aa20377-0ab9-4205-b9aa-24640a4641e7 2026-05-29 Warnings Exact identifier application number: M020 Ciele Blush and Protect Sugar ZINC OXIDE Ciele LLC 52f3a9f6-a226-6723-e063-6394a90a8706 2026-05-29 Warnings Exact identifier application number: M020 KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN TITANIUM DIOXIDE AND ZINC OXIDE LOreal USA Products Inc 294e6049-12b5-4b45-ae00-8ee1d9d2a1a4 2026-05-29 Warnings Exact identifier application number: M020 Daily Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 52f818f4-8485-b228-e063-6294a90a9fe3 2026-05-29 Warnings Exact identifier application number: M020 Dr.G BRIGHT TONING UP TINTED SUNSCREEN ZINC OXIDE, OCTISALATE, HOMOSALATE GOWOONSESANG COSMETICS CO., LTD. 30d34459-b7fb-b0c6-e063-6294a90a08ac 2026-05-28 Warnings Exact identifier application number: M020 Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREEN ZINC OXIDE GOWOONSESANG COSMETICS CO., LTD. 30d49f24-3e13-385f-e063-6294a90ab5c8 2026-05-28 Warnings Exact identifier application number: M020 Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREEN HOMOSALATE, OCTISALATE, AVOBENZONE GOWOONSESANG COSMETICS CO., LTD. 30d53b8a-7e35-0b2b-e063-6294a90aa8df 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect Berri ZINC OXIDE Ciele LLC 52e16cbc-b452-db18-e063-6394a90a4081 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect June ZINC OXIDE Ciele LLC 52e1c504-f0ee-2853-e063-6394a90a3139 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect January ZINC OXIDE Ciele LLC 52e186df-06aa-6528-e063-6294a90a3888 2026-05-28 Warnings Exact identifier application number: M020 Ciele Blush and Protect Berri ZINC OXIDE Ciele LLC 52e1398d-b170-ea89-e063-6294a90a7d24 2026-05-28 Warnings Exact identifier application number: M020 TIZO ULTRA NON TINTED MINERAL SUNSCREEN ZINC OXIDE 20% Fallien Cosmeceuticals, LTD 30d30610-2e6c-418c-bbcf-4ecd7f61be93 2026-05-28 Warnings Exact identifier application number: M020 Creme Foundation ZINC OXIDE Lauren Brooke Cosmetiques LLC 4d09907e-ddcd-9d62-e063-6394a90acf3f 2026-05-28 Warnings Exact identifier application number: M020 GOONGBE Moisture Sun Cushion Mild SPF 50 ZINC OXIDE Zero to Seven Inc. 1e8720b4-5e8b-dc8b-e063-6394a90aad34 2026-05-27 Warnings Exact identifier application number: M020 GOONGBE Fresh Sun Stick Mild SPF 50 ZINC OXIDE Zero to Seven Inc. 1e8727a4-0dc0-19dc-e063-6394a90a82b6 2026-05-27 Warnings Exact identifier application number: M020 Tallow and Sol SUNSCREEN SPF30 NON-NANO ZINC OXIDE 20% Guangzhou Shengyanghui Industrial Trading Co., Ltd 52c9dc0a-41f7-3e8a-e063-6394a90a8fca 2026-05-27 Warnings Exact identifier application number: M020 Tallow and SolSUNSCREEN SPF50 NON-NANO ZINC OXIDE 25% Guangzhou Shengyanghui Industrial Trading Co., Ltd 52cb56cf-f092-9f86-e063-6394a90ac2d3 2026-05-27 Warnings Exact identifier application number: M020 SPF 50 Mineral Sunscreen Face and Body ZINC OXIDE Toddle Born Wild, Inc. e97d82fe-cd45-43a5-9c1f-3900025240a1 2026-05-27 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