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 10 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK ZINC OXIDE Younique, LLC 2173666b-6c72-449d-9f40-098ea174f3e1 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEP ZINC OXIDE Younique, LLC 360ceb90-bec6-4fec-820a-a4d65008b872 2026-07-23 Warnings Exact identifier application number: M020 Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEP ZINC OXIDE Younique, LLC 86c33a9e-9132-4377-8688-41e5844de62c 2026-07-23 Warnings Exact identifier application number: M020 MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTURE AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Forest Avenue Co., Ltd. edbfcf21-96c6-4519-8b08-f9b5ada7d1d7 2026-07-23 Warnings Exact identifier application number: M020 LBEL SOLUTIONS PRO NUDE SKIN BASE SERUM TINT COBERTURA ANTIMANCHAS FPS 15 ANTI DARK SPOT COVERAGE SERUM TINT FOUNDATION SPF 15 CHAMPAGNE 170-N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 574c96e9-77a2-778f-e063-6394a90a0aae 2026-07-23 Warnings Exact identifier application number: M020 SKINSUIT LIP SPF 30 ZINC OXIDE Skin Authority LLC cb24d714-f6cd-4518-b146-627cfe6c2ccd 2026-07-23 Warnings Exact identifier application number: M020 SKINSUIT FACE SPF 50 ZINC OXIDE Skin Authority LLC 389fc528-fda5-485a-ab37-f99fcf3ed0b3 2026-07-23 Warnings Exact identifier application number: M020 True Coast SPF 50 Mineral Sunscreen ZINC OXIDE 18%, TITANIUM DIOXIDE 6% Foshan Sugar Max Cosmetics CO.,Ltd 5379466d-8d14-5fc2-e063-6394a90abd7e 2026-07-22 Warnings Exact identifier application number: M020 Native Daily Face Mineral Sunscreen Broad Spectrum SPF 30 Coconut and Pineapple ZINC OXIDE The Procter & Gamble Manufacturing Company 3519e5bc-8c07-0617-e063-6394a90a65ae 2026-07-22 Warnings Exact identifier application number: M020 Tula Skincare Radiant Skin Brightening Serum Skin Tint Broad Spectrum SPF 30 01 Very Light Neutral AVOBENZONE, AND OCTISALATE The Procter & Gamble Manufacturing Company 366144c4-ec80-e435-e063-6394a90aba54 2026-07-22 Warnings Exact identifier application number: M020 Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation OCTINOXATE AND TITANIUM DIOXIDE SICOS ET CIE 571f23e9-1126-e32d-e063-6294a90a9951 2026-07-21 Warnings Exact identifier application number: M020 YSE Beauty Instant Glow Trio AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MSS Beauty LLC 6742e089-565a-40bc-8ffa-ec06e7986028 2026-07-21 Warnings Exact identifier application number: M020 YSE Beauty The Roadies Packable AM Routine AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MSS Beauty LLC b0844331-d277-4cfb-957a-d8f949883684 2026-07-21 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Day Cream SPF 30 AVOBENZONE,OCTISALATE,OCTOCRYLENE BCM Cosmetique SAS 328f96bc-fb68-33dc-e063-6294a90aecfa 2026-07-21 Warnings Exact identifier application number: M020 Sunscreen In the Raw SPF 50 ZINC OXIDE Biomin LLC 625523f0-366f-4148-b927-d726b7d1b9f4 2026-07-20 Warnings Exact identifier application number: M020 MENS SPF50 ALL IN ONE SUNSCREEN MENS SPF50 ALL IN ONE SUNSCREEN Lance (Guangzhou) Biological Technology Co., Ltd. 57074480-77fd-cc06-e063-6294a90a28d4 2026-07-20 Warnings Exact identifier application number: M020 Native Mineral Suncare Broad Spectrum SPF 30 Coconut and Pineapple ZINC OXIDE The Procter & Gamble Manufacturing Company 3a87ddee-241d-f972-e063-6294a90a7e89 2026-07-20 Warnings Exact identifier application number: M020 Native Mineral Suncare Daily Face Broad Spectrum SPF 30 Unscented ZINC OXIDE The Procter & Gamble Manufacturing Company 3a893b13-e7f5-c5b1-e063-6394a90a4253 2026-07-20 Warnings Exact identifier application number: M020 Omnilux Mineral Facial Sunscreen ZINC OXIDE The Lotus Global Group, Inc, dba GlobalMed Technologies 5710c84b-9d6b-da4d-e063-6394a90a0737 2026-07-20 Warnings Exact identifier application number: M020 Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc 5711364c-f9b4-bfa6-e063-6294a90ace4a 2026-07-20 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