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 32 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Frase Skin SPF 30 Face Sunscreen Activated Vitamin D Technology AVOBENZONE, OCTISALATE, OCTOCRYLENE Frase Skin PTY LTD d904fd23-a3a1-4564-8eec-13a4c96e23f7 2026-05-12 Warnings Exact identifier application number: M020 Hawaii Sol Natural Non-Nano Sunscreen SPF 50 ZINC OXIDE Caribbean Sol International, LLC 24678326-547f-427d-a481-d8c40380e30a 2026-05-12 Warnings Exact identifier application number: M020 Caribbean Sol Natural Non-Nano Sunscreen SPF 50 ZINC OXIDE Caribbean Sol International, LLC 20aadcf6-16a3-4344-837b-b91ba8753fb0 2026-05-12 Warnings Exact identifier application number: M020 Cancer Council Daily Face Moisturizer SPF50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vitality US Co. 1b4333b8-5747-c591-e063-6294a90a9924 2026-05-12 Warnings Exact identifier application number: M020 Lather Daily Defense Mineral SPF 45 Facial Sunscreen ZINC OXIDE Lather, Inc. 50c732a0-b282-d61b-e063-6294a90aa76b 2026-05-12 Warnings Exact identifier application number: M020 Hampton Sun SPF50 Mineral Face Sunscreen HOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00% S&C Hampton Sun LLC f1c5310b-c43b-475d-8a50-d55759ad3164 2026-05-12 Warnings Exact identifier application number: M020 Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark TITANIUM DIOXIDE AND ZINC OXIDE SENT, Inc. aedde765-931f-430e-9fc3-d87bde2b78cd 2026-05-12 Warnings Exact identifier application number: M020 Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium TITANIUM DIOXIDE AND ZINC OXIDE SENT, Inc. 417305d7-d32e-4bc9-8f77-0a42b6bdecf5 2026-05-12 Warnings Exact identifier application number: M020 Stellar Mineral Glow Guard Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Stellar Beauty Co. 0f7ee8c6-3af2-42a2-b341-3e0da42c7c93 2026-05-11 Warnings Exact identifier application number: M020 Frase Skin SPF 50 Activated Vitamin D Technology Cool AVOBENZONE, OCTISALATE, OCTOCRYLENE Frase Skin PTY LTD 0a5cc927-0fd3-4c8f-b847-a274f6eb09fb 2026-05-11 Warnings Exact identifier application number: M020 Miami Beach Bum SPF 30 Bodyguard Face Body Mineral Sunscreen ZINC OXIDE Miami Beach Bum 3b778530-9af0-48eb-bd91-d9ac99f2983f 2026-05-11 Warnings Exact identifier application number: M020 Walgreens SPF 60 Melt-in Milk Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Walgreens 345955ea-f37a-8629-e063-6294a90aa7cc 2026-05-11 Warnings Exact identifier application number: M020 DERMATONE SPF50 Sunscreen AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5% Dermatone Labs LLC 4dc81593-4790-403f-9d49-6569bcd0fea2 2026-05-11 Warnings Exact identifier application number: M020 The Perfect Derma Mineral Perfection Broad Spectrum SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Bella Medical Products LLC 518f69fc-fd39-8195-e063-6294a90a3fdd 2026-05-11 Warnings Exact identifier application number: M020 Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral Sunscreen RADICAL RESCUE SPF 30 MINERAL SUNSCREEN ProTransit, Inc. 38e0139c-bb87-55ba-e063-6294a90a82ee 2026-05-11 Warnings Exact identifier application number: M020 ChapStick Moisturizer Original SPF 15 SPF 15 SKIN PROTECTANT Suave Brands Co., LLC 47bfa8ea-4d8d-cd13-e063-6394a90a71aa 2026-05-11 Warnings Exact identifier application number: M020 EELHOE Sunscreen TITANIUM DIOXIDE Shantou Eelhoe Daily Chemical Technology Co., Ltd. 5196ccb0-4515-7e40-e063-6394a90a09bd 2026-05-11 Warnings Exact identifier application number: M020 Mediheal Madecassoside Moisture Sun Serum HOMOSALATE, OCTOCRYLENE, OCTISALATE, ENSULIZOLE 74005 47c66535-8287-9b74-e063-6394a90ac3b6 2026-05-10 Warnings Exact identifier application number: M020 SPF 30 Sunscreen HOMOSALATE 10% OCTISALATE 5% AVOBENZONE 3% Coconut Caliente Costa Rica LLC af56f16a-2643-4bfc-9e05-dfba79cdab8a 2026-05-08 Warnings Exact identifier application number: M020 Iris and Romeo Weekend Skin Cool Glow ZINC OXIDE Iris and Romeo 514f7d70-7b8b-0992-e063-6394a90a1e98 2026-05-08 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