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 239 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sheglam Dew and Done Skin Tint with SPF 20 Nude ZINC OXIDE EVER FAME PTE. LTD. 2abd8527-72a5-1564-e063-6294a90ad8d3 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Nutmeg ZINC OXIDE EVER FAME PTE. LTD. 2abdda5e-0f52-ae46-e063-6394a90ae6f5 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Porcelain ZINC OXIDE EVER FAME PTE. LTD. 2abdddbc-d891-7c4d-e063-6294a90a8162 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Russet ZINC OXIDE EVER FAME PTE. LTD. 2abe084b-7478-e923-e063-6394a90ac941 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Peach ZINC OXIDE EVER FAME PTE. LTD. 2abdca50-ffc4-8c36-e063-6394a90af766 2025-01-02 Warnings Exact identifier application number: M020 Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes) AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Distribuidora Comercial Jafra, S.A. de C.V. c3bacceb-63a8-098c-e053-2995a90acd64 2025-01-02 Warnings Exact identifier application number: M020 Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16 ZINC OXIDE REJUVA MINERALS INC 3d83c220-1801-4193-b6a8-c777f412c173 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Saddle ZINC OXIDE EVER FAME PTE. LTD. 2abf69c5-07d7-252d-e063-6394a90a292b 2025-01-02 Warnings Exact identifier application number: M020 Sheglam Dew and Done Skin Tint with SPF 20 Sand ZINC OXIDE EVER FAME PTE. LTD. 2abf7869-4418-7738-e063-6394a90ae89d 2025-01-02 Warnings Exact identifier application number: M020 Good Weather Skin The One Daily Sun SPF 30 ZINC OXIDE Good Weather Inc. 2ac30544-5ece-18ed-e063-6394a90a6a0d 2025-01-02 Warnings Exact identifier application number: M020 Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plus OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE Exelencia importers Corp. 283c2780-5ad5-38f1-e063-6294a90ac336 2025-01-01 Warnings Exact identifier application number: M020 EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUS OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE Biocosmetica Exel Argentina SRL 2aabf782-65f9-e894-e063-6394a90a1ea3 2025-01-01 Warnings Exact identifier application number: M020 EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUS OCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLE Biocosmetica Exel Argentina SRL 2aad5b97-e64b-c678-e063-6294a90aa8c6 2025-01-01 Warnings Exact identifier application number: M020 TIBENA ALWAYS REAL SUN BLOCK UV SPF 45 AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENE KONAD CO LTD 2aafbd33-710a-201e-e063-6294a90ab1bb 2025-01-01 Warnings Exact identifier application number: M020 THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-Free ENSULIZOLE, TITANIUM DIOXIDE fmg Co.Ltd d30ac897-3a30-7bba-e053-2995a90ac342 2025-01-01 Warnings Exact identifier application number: M020 THEFACESHOP Cushion CC Total Cover SPF 50 Apricot Beige ENSULIZOLE, TITANIUM DIOXIDE fmg Co.Ltd d30b0588-b0f4-39a8-e053-2a95a90abb35 2025-01-01 Warnings Exact identifier application number: M020 THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-Free ENSULIZOLE, TITANIUM DIOXIDE fmg Co.Ltd d30aeaa6-3423-401c-e053-2a95a90a8fe9 2025-01-01 Warnings Exact identifier application number: M020 THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige ENSULIZOLE, TITANIUM DIOXIDE fmg Co.Ltd d30afd94-8bcd-01bc-e053-2a95a90afb49 2025-01-01 Warnings Exact identifier application number: M020 THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50 ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE fmg Co.Ltd d30b156a-b9b1-499b-e053-2a95a90ada6a 2025-01-01 Warnings Exact identifier application number: M020 THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50 ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE fmg Co.Ltd d30b183d-a54d-752c-e053-2a95a90a24fc 2025-01-01 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