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 222 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Halo Glow Skin Tint SPF 50 84507 ZINC OXIDE e.l.f. Cosmetics, Inc. 31314118-0fd6-5549-e063-6394a90a9d1f 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84506 ZINC OXIDE e.l.f. Cosmetics, Inc. 313119be-c1f2-4cb0-e063-6294a90a03ca 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF50 -84516 ZINC OXIDE e.l.f. Cosmetics, Inc. 312dd439-5cc8-e034-e063-6394a90a5c76 2025-03-25 Warnings Exact identifier application number: M020 Halo Glow Skin Tint SPF 50 84504 ZINC OXIDE e.l.f. Cosmetics, Inc. 223efabb-d018-c337-e063-6394a90a5605 2025-03-25 Warnings Exact identifier application number: M020 IT Cosmetics Your Skin But Better CC Plus Color Correcting Full Coverage Antiaging Hydrating Serum Broad Spectrum SPF 50 Plus Clear Sunscreen HOMOSALATE, OCTISALATE AND OCTOCRYLENE IT COSMETICS, LLC 9f8786cc-bef6-4449-8f31-dfc08de77734 2025-03-25 Warnings Exact identifier application number: M020 it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All Shades TITANIUM DIOXIDE AND ZINC OXIDE IT COSMETICS, LLC b7d184fb-4a9a-4720-9b00-bf0caa257a8c 2025-03-25 Warnings Exact identifier application number: M020 KISS New York Tinted Moisturizer ZINC OXIDE IVY ENTERPRISES, INC. 30cce5b1-ed41-5bf2-e063-6394a90aaf1d 2025-03-24 Warnings Exact identifier application number: M020 KISS New York Tinted Moisturizer ZINC OXIDE IVY ENTERPRISES, INC. 30df95da-4868-1414-e063-6294a90acdac 2025-03-24 Warnings Exact identifier application number: M020 KISS New York Tinted Moisturizer ZINC OXIDE IVY ENTERPRISES, INC. 30e1bd3c-6a0b-a8f8-e063-6394a90acfb7 2025-03-24 Warnings Exact identifier application number: M020 KISS New York Tinted Moisturizer ZINC OXIDE IVY ENTERPRISES, INC. 30e1b4c9-0d77-b08a-e063-6394a90af683 2025-03-24 Warnings Exact identifier application number: M020 KISS New York Tinted Moisturizer ZINC OXIDE IVY ENTERPRISES, INC. 30e1ff3f-0fd0-2880-e063-6294a90a462f 2025-03-24 Warnings Exact identifier application number: M020 KISS New York Tinted Moisturizer ZINC OXIDE IVY ENTERPRISES, INC. 30e25241-0d2b-8c04-e063-6294a90a44b9 2025-03-24 Warnings Exact identifier application number: M020 Walgreens SPF 50 Clear Complexion Face Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY 311ae6d6-d466-3f1d-e063-6294a90ab3dd 2025-03-24 Warnings Exact identifier application number: M020 DOMINAS DARK SPOT TINTED SUNSCREEN OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE LG H&H CO., LTD. 2b6140cf-7e34-1658-e063-6394a90a3271 2025-03-24 Warnings Exact identifier application number: M020 CVS Health SPF 70 Ultra Sheer AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CVS Pharmacy 311de9db-941c-5af9-e063-6294a90a3a13 2025-03-24 Warnings Exact identifier application number: M020 CVS Health SPF 70 Beach Guard Clear AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CVS Pharmacy 311e6378-5afa-d7eb-e063-6394a90a7728 2025-03-24 Warnings Exact identifier application number: M020 Naked Sundays Golden Glow Body Sunscreen SPF50 100ml NAKED SUNDAYS GOLDEN GLOW BODY SUNSCREEN SPF50 100ML NAKED SUNDAYS PTY LTD e182a39b-89b1-7756-e053-2a95a90ab619 2025-03-23 Warnings Exact identifier application number: M020 ANTIOXIDANT BODY SUNSCREEN CREME SPF50 BROAD SPECTRUM AVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G, NAKED SUNDAY PTY LTD eb7a84a8-3e25-9988-e053-2a95a90a58a9 2025-03-23 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50 TITANIUM OXIDE, ZINC OXIDE NAKED SUNDAYS PTY LTD 01273e8c-aef0-d800-e063-6294a90abd49 2025-03-23 Warnings Exact identifier application number: M020 NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50 TITANIUM OXIDE, ZINC OXIDE NAKED SUNDAYS PTY LTD 01221d57-9eec-7e77-e063-6394a90a6042 2025-03-23 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