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 154 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35 AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENE CLINIQUE LABORATORIES LLC 44fe7468-001c-f2ee-e063-6394a90ae3b4 2025-12-02 Warnings Exact identifier application number: M020 ATTITUDE Super Leaves Lip Balm SPF15 Unscented ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44ff1fc0-9ac5-2c9a-e063-6294a90a4632 2025-12-02 Warnings Exact identifier application number: M020 ATTITUDE Sunly Lip Balm SPF 15 Coconut ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44ff5675-fd8d-b665-e063-6294a90a1e0b 2025-12-02 Warnings Exact identifier application number: M020 ATTITUDE Sunly Lip Balm SPF 15 Pineapple ZINC OXIDE 9055-7588 Qubec Inc.DBA ATTITUDE 44ffb35b-80f4-7ddb-e063-6394a90a2cbb 2025-12-02 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 44ffd469-0205-846f-e063-6294a90af6b5 2025-12-02 Warnings Exact identifier application number: M020 COSRX VITAMIN E VITALIZING SUNSCREEN COSRX inc. daf0291e-770c-eaf2-e053-2a95a90a0b67 2025-12-01 Warnings Exact identifier application number: M020 Centellian24 Madeca Derma Shield Vital Dewy Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTROCRYLENE 70541 44e0098c-170f-ca51-e063-6294a90aed20 2025-12-01 Warnings Exact identifier application number: M020 Centellian24 Madeca Derma Shield Vital Sun Essence AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 70541 44e194cd-ea61-71b3-e063-6394a90ac486 2025-12-01 Warnings Exact identifier application number: M020 Venture Performance Sun Protection Mineral Sunscreen SPF 50 ZINC OXIDE Venture Performance Inc 630fc5c2-a315-4e26-9bd9-5f8533d75908 2025-12-01 Warnings Exact identifier application number: M020 EMINENCE Red Currant Protective Moisturizer OCTINOXATE, ZINC OXIDE Eminence Organic Skin Care 7eca62af-6f70-44ec-879e-74712163c4e0 2025-12-01 Warnings Exact identifier application number: M020 CHARLOTTE TILBURY Broad Spectrum SPF 50 Sunscreen Invisible UV Flawless Poreless Primer AVOBENZONE, OCTINOXATE, OCTISALATE AND OCTOCRYLENE Charlotte Tilbury Beauty Ltd. 2b215ecb-7c3a-63db-e063-6394a90aa88f 2025-12-01 Warnings Exact identifier application number: M020 P.CALM Water Barrier Sunscreen SPF 50 Broad Spectrum HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE LIFE WITHCORPORATION Inc. 44ea9fb4-8e01-6969-e063-6294a90a6a94 2025-12-01 Warnings Exact identifier application number: M020 ROC MULTI CORREXION - EVEN TONE AND LIFT - 5-In-1 Chest, Neck, and Face Cream Sunscreen - Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATA, OCTISALATE, OCTOCRYLENE Roc Skincare 2b3656d6-4b3a-9ef2-e063-6294a90acaa6 2025-12-01 Warnings Exact identifier application number: M020 UNCOMPLIKATED MAKEUP SETTING SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Rare Beauty Brands Inc. 44ec0db5-4437-e4a3-e063-6294a90a9a00 2025-12-01 Warnings Exact identifier application number: M020 RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RoC Skincare 2888a198-116b-8441-e063-6394a90a0f95 2025-12-01 Warnings Exact identifier application number: M020 ReefSafe Very High Sun Protection sunscreen ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44ec619f-ed3b-2fd3-e063-6294a90a858b 2025-12-01 Warnings Exact identifier application number: M020 Reef safe - Face and Body sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38603298-e8da-e4c7-e063-6394a90aca3b 2025-12-01 Warnings Exact identifier application number: M020 ReefSafe Baby and Toddlers Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44dd513e-ebaa-0d6a-e063-6394a90a78b7 2025-11-30 Warnings Exact identifier application number: M020 Safe4Kidz Natural Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44ddc0ae-a977-3adf-e063-6294a90a0898 2025-11-30 Warnings Exact identifier application number: M020 Safe4Kidz Baby Zinc Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 44ddc4d8-3f3b-5d11-e063-6294a90ae88a 2025-11-30 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