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 181 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Petroleum-Free Lip Balm OCTINOXATE AND OXYBENZONE Medline Industries, LP 6125d98a-6fc7-4f50-924e-3b1f7ee951f4 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 1) ZINC OXIDE Resette, Inc dc89429a-022c-dd10-e053-2a95a90ac26a 2025-10-09 Warnings Exact identifier application number: M020 Daybird Tinted Skincare (SHADE 2) ZINC OXIDE Resette, Inc dc89ab76-da2f-4f6f-e053-2995a90a8bcb 2025-10-09 Warnings Exact identifier application number: M020 Dr Lift SPF 50 Clear Stick AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Spa de Soleil 40c11b19-fc91-2033-e063-6394a90a5a5f 2025-10-09 Warnings Exact identifier application number: M020 Black Girl Sunscreen Make It Mineral Baby ZINC OXIDE Black Girl Sunscreen 302bccc6-7bf3-cc69-e063-6294a90a625c 2025-10-09 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08f0436b-85b6-5099-e063-6294a90a4c2e 2025-10-09 Warnings Exact identifier application number: M020 CoreTex Professional Outdoor Skin Protection Wallet CORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLET CoreTex Products Inc f57bc089-405b-cdcd-e053-2995a90a9d12 2025-10-09 Warnings Exact identifier application number: M020 Mist Me SPF-40 ZINC OXIDE Cove Suncare LLC b7f09089-54a4-4f60-b632-e3f4321313ec 2025-10-09 Warnings Exact identifier application number: M020 Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Allergan, Inc. 29817fdc-f14c-4013-a8ed-4367f3b2867c 2025-10-09 Warnings Exact identifier application number: M020 Skinny Dip SPF-50 ZINC OXIDE Cove Suncare LLC 7bef2966-9351-4ea6-aeed-0d568376d86b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0ba2e9-126f-13c0-e063-6394a90aa6a4 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 08997bd4-d6b9-fffc-e063-6294a90a77ae 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE Kenvue Brands LLC 75f81b2d-cabc-443f-b4b5-76bd2321826b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 1390f863-709e-412b-9a25-b65217844e44 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC ccc2e40b-5301-4055-8a89-47366687cfb7 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0dd2e4-3dda-c872-e063-6294a90a20a3 2025-10-08 Warnings Exact identifier application number: M020 ScalpHair MistSunscreen SPF30 COOLA SCALPHAIR MIST ORGANIC SUNSCREEN SPF30 COOLA LLC c7d2098f-6fdf-68e5-e053-2a95a90a1898 2025-10-08 Warnings Exact identifier application number: M020 Block Party SPF-50 ZINC OXIDE Cove Suncare LLC 24ffb6ec-d922-40c0-b325-c15f8433027a 2025-10-08 Warnings Exact identifier application number: M020 Sun Kids mineral BLUEBERRY SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE The Natural SKN Company 40945805-6f2e-74a1-e063-6394a90a04a3 2025-10-07 Warnings Exact identifier application number: M020 ProtecTINT 10N HOMOSALATE, OCTISALATE, ZINC OXIDE Supergoop, LLC 0801287f-0df5-4303-e063-6394a90a503b 2025-10-07 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