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 234 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE NEW SEASON DERMATOLOGY, PLLC fecd72a3-c7e5-3dfa-e053-6394a90a7357 2025-01-09 Warnings Exact identifier application number: M020 ERBORIAN DOUBLE SAMPLE CC CREME CLAIR and DORE SPF 25 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES M&L 41b3cf18-dc11-4e1d-802e-5ba25bd87adb 2025-01-09 Warnings Exact identifier application number: M020 ECLIPSE SPF 50 PERFECTINT BEIGE TITANIUM DIOXIDE, ZINC OXIDE SCIENCE OF SKINCARE LLC b69dda25-372f-15d9-e053-2995a90a8d3e 2025-01-09 Warnings Exact identifier application number: M020 PerfecTint Powder SPF 40 All Shades ZINC OXIDE Science of Skincare bb26c010-299e-3dc5-e053-2995a90a2c89 2025-01-09 Warnings Exact identifier application number: M020 Extreme Protect SPF 40 All Shades ZINC OXIDE, TITANIUM DIOXIDE Science of Skincare, LLC. b69db78b-5f0e-8ca2-e053-2a95a90ac88c 2025-01-09 Warnings Exact identifier application number: M020 ECLIPSE SPF 50 ALL SHADES TITANIUM DIOXIDE, ZINC OXIDE SCIENCE OF SKINCARE LLC 49df51e6-be9a-41be-b3e1-bfc062aaceaa 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Mineral Suns Stick - Tinted SPF 45 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 44a6ff9b-8067-4f32-acb2-4ede54c79e6e 2025-01-09 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - SUNKISSED ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC c45b59d8-0196-4dce-bfaa-57c47f655fe8 2025-01-09 Warnings Exact identifier application number: M020 TiZO Tinted Lip Protection SPF 45 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Prime and Protect SPF 40 (Tinted) TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 1088fbf6-5790-490d-b272-ec281b4b76fa 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Prime and Protect SPF 40 (Non-Tinted) TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD f106f52b-2157-46c7-9f7c-50f43a649050 2025-01-09 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKS ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC 5c98bacb-8bbd-47b8-8987-50be1ed34fc0 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Moisture ZINC OXIDE Fallien Cosmeceuticals, LTD db682516-6c8f-4009-a9ec-e21dfc64ce15 2025-01-09 Warnings Exact identifier application number: M020 L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light Medium OCTOCRYLENE, ZINC OXIDE L'BRI Health & Beauty bcd22c9a-2db6-4653-9ab5-825f3f5cc420 2025-01-08 Warnings Exact identifier application number: M020 L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light OCTOCRYLENE, ZINC OXIDE L'BRI Health & Beauty c66c2a54-97c8-4904-a44a-b3cf790837f5 2025-01-08 Warnings Exact identifier application number: M020 Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Tempo Industries, Inc. af9aa56d-2f8a-55b9-e053-2a95a90a3258 2025-01-08 Warnings Exact identifier application number: M020 Baby Mineral Sunscreen Probiotics SPF55 ZINC OXIDE Hello Bello 0191b2e4-bcc5-541a-e063-6294a90a0e78 2025-01-08 Warnings Exact identifier application number: M020 Kids Face and Body Sunscreen SPF 50 ZINC OXIDE Hello Bello 01cc4ea0-e3de-32f1-e063-6394a90a1375 2025-01-08 Warnings Exact identifier application number: M020 Baby Mineral Sunscreen SPF55 ZINC OXIDE Hello Bello 0190eeaf-c5a0-3253-e063-6294a90a43c4 2025-01-08 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 50 ZINC OXIDE Hello Bello 01cc205b-a345-262a-e063-6394a90a955c 2025-01-08 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