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 82 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Blue Lizard Baby SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 32d6e04a-fa30-ba48-e063-6394a90a1bbf 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Kids SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 2f780daa-4c91-5a68-e063-6394a90afd41 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sensitive SPF 50 ZINC OXIDE Crown Laboratories 99839894-9695-2cd1-e053-2995a90acba6 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard SPF 15 Lip Balm ZINC OXIDE Crown Laboratories 1bf8fb7e-9d5b-86d4-e063-6294a90afddc 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Kids SPF 50 ZINC OXIDE Crown Laboratories 9983563c-1e63-0748-e053-2a95a90a971e 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Baby SPF 50 ZINC OXIDE Crown Laboratories 9948f5b8-43bd-1c99-e053-2a95a90a6121 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sheer SPF 50 Sunscreen ZINC OXIDE Crown Laboratories 3368f1cb-c341-e886-e063-6394a90a9b7c 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sport SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 2f3844d8-0367-aad9-e063-6294a90a1fce 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sheer Face SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 30cd79da-2f25-a42a-e063-6394a90a8332 2026-01-12 Warnings Exact identifier application number: M020 ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREEN TITAMIUN DIOXIDE, ZINC OXIDE UCL Co., Ltd. 4837b4f6-ada9-801a-e063-6294a90a8547 2026-01-12 Warnings Exact identifier application number: M020 Intellishade Original SPF 45 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE Revision, LLC e213a681-eb22-69c0-e053-2995a90a899e 2026-01-12 Warnings Exact identifier application number: M020 GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASE HOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDE ORIGINS NATURAL RESOURCES INC. 48393640-4b97-04de-e063-6294a90aa6a6 2026-01-12 Warnings Exact identifier application number: M020 Hale and Hush Broad Spectrum SPF 30 SPF 30 ZINC OXIDE Eclectic Solutions LLC 0530904f-b02c-d8cf-e063-6294a90aa5a7 2026-01-12 Warnings Exact identifier application number: M020 Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Minori Inc. 1d4e2654-1638-0d01-e063-6394a90af303 2026-01-12 Warnings Exact identifier application number: M020 LUXURY BODY RITUAL HYDRATING SPF 30 ZINC OXIDE JANE STREET LLC 15e9d688-f226-1a19-e063-6394a90ab906 2026-01-12 Warnings Exact identifier application number: M020 BROAD SPECTRUM SPF50 SPF 50 AVOBENZONE, HOMOSALATE OCTISALATE, NAKED SUNDAYS PTY LTD 0426b1e9-063b-c1e6-e063-6294a90a2554 2026-01-11 Warnings Exact identifier application number: M020 SPF30 MINERAL SUNSCREEN MOUSSE ZINC OXIDE Aopline Biotechnology (Guangzhou) Co., Ltd. 48031a0f-c2ed-5424-e063-6294a90ad0ff 2026-01-10 Warnings Exact identifier application number: M020 SPF 30 MINERAL WHIPPED CREAMS SHIMMER ZINC OXIDE Aopline Biotechnology (Guangzhou) Co., Ltd. 48037a05-722e-4231-e063-6294a90ac51f 2026-01-10 Warnings Exact identifier application number: M020 ODLUMIVIE Tinted Mineral Sunscreen ZINC OXIDE,TITANIUM DIOXIDE Guangzhou Meijiao Medical Biotechnology Co., Ltd. 480d6e65-f6dc-d2a5-e063-6294a90a24a1 2026-01-10 Warnings Exact identifier application number: M020 Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE FUTURE 8 LLC 9922f132-f6a5-41ca-847a-936b20bf1716 2026-01-09 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