Home NDC 84616-007 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM
Product NDC 84616-007
11-digit product format 846160007
Labeler code 84616
Product ID 84616-007_4fea1efd-c18a-817f-e063-6294a90a8afb
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 2027-12-31
Current FDA listing Yes 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 SPF50 BROAD SPECTRUM
Listing expiration 2027-12-31 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 84616-007-01 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 50 mL in 1 TUBE CREAM 50 5 84616-007-02 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 10 mL in 1 TUBE CREAM 10 5 84616-007-03 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 2 in 1 BOX CREAM 2 5 84616-007-04 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 60 mL in 1 TUBE CREAM 60 5 84616-007-05 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 30 mL in 1 TUBE CREAM 30 5
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 141 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Physical Block Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tucson Acne Clinic 30ddc3d7-76df-3344-e063-6294a90a65ae 2025-12-09 Warnings Exact identifier application number: M020 Tinted Physical Block Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tucson Acne Clinic 30ddf80c-8496-0f47-e063-6394a90afc18 2025-12-09 Warnings Exact identifier application number: M020 Lightly Tinted Mineral Block Sunscreen ZINC OXIDE Tucson Acne Clinic 30dfa973-3217-1e18-e063-6294a90a8d41 2025-12-09 Warnings Exact identifier application number: M020 Lightly Tinted Mineral Block Sunscreen ZINC OXIDE Tucson Acne Clinic 30df0039-4dc1-7355-e063-6394a90ae800 2025-12-09 Warnings Exact identifier application number: M020 Advanced Lip Guard TITANIUM DIOXIDE, ZINC OXIDE ADVANCED DERMATOLOGY 32e66ff3-ae1a-4a2a-e063-6294a90a7963 2025-12-09 Exact identifier application number: M020 Skin Tone Defender 20% Zinc Oxide ZINC OXIDE Cali Skin Care LLC 308c711d-4c3e-1208-e063-6394a90a9cc2 2025-12-09 Warnings Exact identifier application number: M020 Advanced Light Perfecting Sunscreen ZINC OXIDE ADVANCED DERMATOLOGY 32d781ca-7993-9875-e063-6294a90a5c26 2025-12-09 Exact identifier application number: M020 Advanced Light Perfecting Sunscreen ZINC OXIDE Advanced Dermatology 32e6c080-6ce3-8d99-e063-6294a90ac1bc 2025-12-09 Exact identifier application number: M020 StriVectin multi-action Super-C SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE StriVectin Operating Company, Inc. b299df12-fbdd-437b-9bfa-4846e361725a 2025-12-09 Warnings Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L.S. MOORE LLC 37f1e019-32c4-b733-e063-6394a90aca28 2025-12-09 Exact identifier application number: M020 RADIANCE ZINC OXIDE L.S. MOORE LLC 37f254cb-9de5-8f67-e063-6294a90a4e28 2025-12-09 Exact identifier application number: M020 StriVectin Advanced Retinol Daily Repair Moisturizer SPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE StriVectin Operating Company, Inc. cfbdbba8-a739-fd32-e053-2a95a90a6f31 2025-12-09 Warnings Exact identifier application number: M020 Hint of Tint ZINC OXIDE L.S. MOORE LLC 37f20c14-070e-4f86-e063-6294a90ad4c2 2025-12-09 Exact identifier application number: M020 Hint of Tint ZINC OXIDE L.S. MOORE LLC 37f330a0-790a-1656-e063-6294a90a691c 2025-12-09 Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L.S. MOORE LLC 37f2e363-e85f-f601-e063-6294a90ab120 2025-12-09 Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L MOORE AESTHETICS 37f1ac8c-3bfb-10da-e063-6294a90a8ca8 2025-12-09 Exact identifier application number: M020 RoC Multi Correxion Revive and Glow Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RoC Skincare 40d4cfeb-fb00-801e-e063-6394a90ada6b 2025-12-09 Warnings Exact identifier application number: M020 RADIANCE ZINC OXIDE L.S. MOORE LLC 37f2b104-0213-c88c-e063-6294a90a4247 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Moisturizing Lightly Tinted ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 3350c673-2afd-a00a-e063-6294a90aa196 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Dry Touch NT TITANIUM DIOXIDE, ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 334ffc49-3196-0995-e063-6394a90ad559 2025-12-09 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 84616-007-01 84616000701 50 mL in 1 TUBE (84616-007-01) 50 ml 2024-09-18 No No Current 84616-007-02 84616000702 10 mL in 1 TUBE (84616-007-02) 10 ml 2024-12-18 No No Current 84616-007-03 84616000703 2 TUBE in 1 BOX (84616-007-03) / 60 mL in 1 TUBE (84616-007-04) 2 tube 2024-12-20 No No Current 84616-007-04 84616000704 60 mL in 1 TUBE 60 ml Historical 84616-007-05 84616000705 30 mL in 1 TUBE (84616-007-05) 30 ml 2026-04-20 No No Current