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 269 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Banana Boat ZINC OXIDE Edgewell Personal Care Brands LLC 1ce728be-966e-b662-e063-6394a90a0ba8 2024-10-30 Warnings Exact identifier application number: M020 RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE COSMAX USA, INC. 2596a17e-4042-3544-e063-6294a90aa4c9 2024-10-29 Warnings Exact identifier application number: M020 Sunblocz ZINC OXIDE Olen Skin Care Corporation 36fec1f1-5e8b-5764-e054-00144ff8d46c 2024-10-29 Warnings Exact identifier application number: M020 Sunblocz Baby and Kids ZINC OXIDE Olen Skin Care Corporation 35cbb9d5-639c-207a-e054-00144ff88e88 2024-10-29 Warnings Exact identifier application number: M020 ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes) AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ZO Skin Health, Inc. fd7d40fe-178a-e1b1-e053-6294a90a29a1 2024-10-29 Warnings Exact identifier application number: M020 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE ZO Skin Health, Inc. 9a4f5be1-da04-48b9-897a-57f4a3d9d1ec 2024-10-29 Warnings Exact identifier application number: M020 TiZO Ultra Zinc SPF 40 (Non-Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD e4a06973-21bb-4eda-9b74-fc23bee141ab 2024-10-29 Warnings Exact identifier application number: M020 TiZO Ultra Zinc SPF 40 (Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD 36efd48b-910e-4b61-9519-a6d5c7e9a7c3 2024-10-29 Warnings Exact identifier application number: M020 ZO Skin Health Broad-Spectrum Sunscreen SPF 50 TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health, Inc. d817f80b-a998-b67e-e053-2995a90a1971 2024-10-29 Warnings Exact identifier application number: M020 SPF 15 Coconut Lip Balm ZINC OXIDE Naples Soap Company, Inc. 25a7510f-5ef3-9920-e063-6394a90a2079 2024-10-29 Warnings Exact identifier application number: M020 Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face Protection HOMOSALATE, OCTOCRYLENE, AVOBENZONE Bel Star S.A. (Colombia) a7d69691-cecc-798e-e053-2a95a90a995f 2024-10-28 Warnings Exact identifier application number: M020 LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F OCTINOXATE, ZINC OXIDE Bel Star S.A. eea17271-e8c8-ab21-e053-2995a90a2fcc 2024-10-28 Warnings Exact identifier application number: M020 LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BEL STAR SA fd90ffc6-a1e1-e02e-e053-6294a90a4e7c 2024-10-28 Warnings Exact identifier application number: M020 LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 0b782198-58e7-5343-e063-6294a90a3713 2024-10-28 Warnings Exact identifier application number: M020 FHF Elevated Shade 100% Mineral Sunscreen SUNSCREEN Owen Biosciences Inc dabd3b95-01d3-014c-e053-2a95a90a0fec 2024-10-28 Warnings Exact identifier application number: M020 RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BAY BELLE LABS 259653e7-dfe0-44a2-e063-6294a90a416d 2024-10-28 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 8a21acbe-2f3d-cf78-e053-2a95a90a77f6 2024-10-27 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 7961ff9f-75db-4977-e053-2a91aa0ae628 2024-10-27 Warnings Exact identifier application number: M020 Banana Boat Light as air face SUNSCREEN UVA UVB Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 8a1c9a3c-394e-9122-e053-2995a90acb23 2024-10-27 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 8b889b75-07ac-4276-e053-2a95a90a69c6 2024-10-27 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