Home NDC 84616-005-01 ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM
Product NDC 84616-005
Requested package NDC 84616-005-01
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 84616-005 84616-005-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 79 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50 ZINC OXIDE Noble Panacea Labs, Inc. aed57f81-4b7d-42dc-993e-6bb10f93b02a 2026-01-16 Warnings Exact identifier application number: M020 BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE Noon Aesthetics M.R. Ltd 0d9f132c-7630-4261-a0f8-fc7a4377731f 2026-01-16 Warnings Exact identifier application number: M020 BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUM TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE Noon Aesthetics M.R. Ltd f292da7d-ffd2-41c3-9a64-619aab19ff18 2026-01-15 Warnings Exact identifier application number: M020 Multivit Sun Protector TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE Noon Aesthetics M.R. Ltd abdb560d-29be-41dc-ad23-54ea571acb14 2026-01-15 Warnings Exact identifier application number: M020 BeautyBarrier ZINC OXIDE NAKED SUNDAYS PTY LTD 45740afa-230d-4dd5-e063-6394a90a102f 2026-01-15 Warnings Exact identifier application number: M020 Glow This Way OCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATE Koco Life LLC 4619cf96-987a-3e88-e063-6294a90afbe9 2026-01-15 Warnings Exact identifier application number: M020 Reef safe lip balm 01 AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE Cosmuses Cosmetics (Ningbo) Co., Ltd. 486930f2-026b-14b4-e063-6394a90aa031 2026-01-15 Warnings Exact identifier application number: M020 DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE CLINIQUE LABORATORIES LLC 316bf6f8-7d30-2560-e063-6294a90afb8a 2026-01-15 Warnings Exact identifier application number: M020 Wellcare Sunstick Lip Balm AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE BAMKO, LLC ef977575-7ef0-fc09-e053-2a95a90a8993 2026-01-15 Warnings Exact identifier application number: M020 Bali Body Sheer Glow Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Bali Body Pty Ltd 4872793c-a7c0-1b65-e063-6394a90a8b3a 2026-01-15 Warnings Exact identifier application number: M020 Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Volition Beauty 2631de4b-66e3-0547-e063-6394a90a822c 2026-01-15 Warnings Exact identifier application number: M020 AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30 ZINC OXIDE SKINN COSMETICS, LLC 350ed168-ab3b-f314-e063-6394a90a8bbf 2026-01-15 Warnings Exact identifier application number: M020 StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 Sunscreen OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE StriVectin Operating Company, Inc. 4873a262-a19b-555e-e063-6394a90a182a 2026-01-15 Warnings Exact identifier application number: M020 PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50 SUNSCREEN The Center Brands, LLC e843bb6b-257f-4425-95bc-41774e032a09 2026-01-15 Warnings Exact identifier application number: M020 SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50 SUNSCREEN The Center Brands, LLC 1e18f1dd-a4e4-455a-9699-5634b9559678 2026-01-15 Warnings Exact identifier application number: M020 First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE The Procter & Gamble Manufacturing Company 485c345f-0928-fa1a-e063-6294a90aa856 2026-01-14 Warnings Exact identifier application number: M020 NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30 ZINC OXIDE LABORATOIRES DRUIDE INC 19af4441-31b2-72db-e063-6394a90a813c 2026-01-14 Warnings Exact identifier application number: M020 Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30 ZINC OXIDE Sqween LLC 9c3cf35b-4bde-46e3-8abd-5f4d1ad6e486 2026-01-14 Warnings Exact identifier application number: M020 SCENTUAL AROMA BEAUTY SUN VEIL SPF30 TITANIUM DIOXIDE, ZINC OXIDE LABORATOIRES DRUIDE INC 0799ac38-9a41-6579-e063-6394a90ac4b6 2026-01-14 Warnings Exact identifier application number: M020 NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30 ZINC OXIDE LABORATOIRES DRUIDE INC 0b412e24-baf6-e68e-e063-6394a90a5f49 2026-01-14 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