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 91 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMY ZINC OXIDE Kao USA Inc. 26bcb9cd-bfb5-998c-e063-6394a90ab9d6 2026-01-05 Warnings Exact identifier application number: M020 HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD ZINC OXIDE Kao USA Inc. 26cf1320-aae5-2ea0-e063-6394a90a3be2 2026-01-05 Warnings Exact identifier application number: M020 OZE SUN BONDI ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 47b1aae6-0b86-7d48-e063-6294a90a9ece 2026-01-05 Warnings Exact identifier application number: M020 Hybrid SPF SPF 30 OCTOCRYLENE, OCTISALATE, ZINC OXIDE Topiderm, Inc. 5c99f98c-025c-4886-824f-af968033baf4 2026-01-05 Warnings Exact identifier application number: M020 TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 Plus TITANIUM DIOXIDE HEY HONEY INC. 21187805-fae9-476c-81b0-27ffeb0b9911 2026-01-05 Warnings Exact identifier application number: M020 VEAKSON BEEF TALLOW SUNSCREEN ZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACID Guangdong Aimu Biological Technology Co., Ltd 473c241a-1258-1680-e063-6394a90a7d98 2026-01-04 Warnings Exact identifier application number: M020 HYDRATING SUNSCREEN HYDRATING SUNSCREEN Guangzhou Yapeng Refinement Chemical Co., Ltd. 19a3687b-32b0-7c83-e063-6294a90aaf81 2026-01-04 Warnings Exact identifier application number: M020 Bellas Friends Sunscreen Stick ZINC OXIDE Panergytek Usa Inc 478cbdeb-28e4-fa56-e063-6294a90af124 2026-01-04 Warnings Exact identifier application number: M020 Bellas Friends Roll-on Sunscreen TITANIUM DIOXIDE, ZINC OXIDE PANERGYTEK USA INC 478d46ce-14e8-2231-e063-6394a90a3e27 2026-01-04 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Clear Sunshine ZINC OXIDE Cyberderm Laboratories inc. a8646ee4-5e6e-6cdd-e053-2a95a90aee77 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Strawberry Zinnia ZINC OXIDE Cyberderm Laboratories inc. a888396f-489f-7e7c-e053-2995a90aee5b 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Watermelon Lily ZINC OXIDE Cyberderm Laboratories inc. a8889754-8e33-4d2a-e053-2995a90a6080 2026-01-01 Warnings Exact identifier application number: M020 OKeeffes Lip Repair AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE The Gorilla Glue Company/O'Keeffe's Company 6805b3e9-77cb-bfee-e053-2991aa0a8d98 2026-01-01 Warnings Exact identifier application number: M020 Walgreens 50 Pina Colada Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY 4978c811-be34-9fc3-e063-6394a90a2d80 2026-01-01 Warnings Exact identifier application number: M020 Unicorn Snot 35 SPF Glitter Spritz rose gold shimmer AVOBENZONE, OCTISALATE, OCTOCRYLENE Jailbreak Toys, Inc. DBA UNICORN SNOT 498b7c1a-e66d-9736-e063-6394a90a4712 2026-01-01 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Day Cream SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BCM Ltd f7d5aa8a-9f4a-426b-ac9d-9690cf0103e0 2026-01-01 Warnings Exact identifier application number: M020 MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5 ZINC OXIDE Formula 7venz L.L.C. 5f3cdec9-2cc2-4660-827f-d286883d907c 2025-12-31 Warnings Exact identifier application number: M020 SOLARA SUNCARE - GO VACATION GLOW SPF 30 ZINC OXIDE SOLARA SUNCARE, INC. 1f5cb694-f065-7ebc-e063-6394a90a883a 2025-12-31 Warnings Exact identifier application number: M020 SUNSCREEN GLOWING, SPF 30 SUNSCREEN GLOWING LOTION FSA Store Inc 473bcb90-ab7f-170b-e063-6294a90a99d5 2025-12-31 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05ba5966-f0ff-5360-e063-6294a90a0fc9 2025-12-31 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