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 235 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eco Lips Zinc SPF 30 Broad Spectrum Sunscreen Unscented ZINC OXIDE Eco Lips, Inc. febabad6-0bf2-a3f8-e053-6294a90a3aeb 2025-01-08 Warnings Exact identifier application number: M020 LESS EVERY TONE SPF 30 ZINC OXIDE Happy Farm Botanicals, Inc. e91ded4b-987d-17a8-e053-2995a90adc2e 2025-01-08 Warnings Exact identifier application number: M020 Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE ETHEREAL AESTHETICS LLC 065d17cf-bea5-137f-e063-6394a90aeeb3 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE SERRAO, E JOHN MD FACOG fea61544-6684-ad34-e053-6294a90a48f3 2025-01-08 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE New Beginnings Tattoo Removal fea87de3-116f-4774-e053-6394a90a0aad 2025-01-08 Warnings Exact identifier application number: M020 Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE PURA VIDA BODY & MIND SPA, INC. 04b38e97-c4b3-df23-e063-6394a90ae6b7 2025-01-08 Warnings Exact identifier application number: M020 EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Premier Plastic Surgery bc9221fe-89b4-4ad8-e053-2995a90aa041 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Emerald Aesthetics LLC f80f439d-f4f0-fbf3-e053-6294a90ae0ef 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Suzanne's Skin2soul LLC fea667a1-6bec-9819-e053-6394a90a9b96 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE BEAUTY SENSE MEDSPA INC fe93a337-8d2f-35d3-e053-6294a90acb3c 2025-01-08 Warnings Exact identifier application number: M020 Sunscreen Emulsion SPF50plus OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE Guangzhou Senmai Biotechnology Co. 1d560670-026b-bd34-e063-6394a90a9af4 2025-01-08 Warnings Exact identifier application number: M020 Allies of Skin Sunless Tan SPF 50 Daily Self Tanner AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE ALLIES GROUP PTE. LTD. 4d58de8e-875b-4b77-b0ef-b9d760aaced8 2025-01-07 Warnings Exact identifier application number: M020 Pop Zinc Sunscreen ZINC OXIDE Guangzhou Haishi Biological Technology Co., Ltd 2b29ddb2-5730-8a67-e063-6394a90ae416 2025-01-07 Warnings Exact identifier application number: M020 COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUM COOLA LLC bbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c2 2025-01-07 Warnings Exact identifier application number: M020 Advanced Day Ultimate Protect Sunscreen SPF 50 BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE Medik8 Limited 29071920-ba90-871a-e063-6294a90aee27 2025-01-06 Warnings Exact identifier application number: M020 Dimples Bath Co - Sunstick New Kid On The Block ZINC OXIDE Dimples Bath Co. LLC 26f682f4-2440-f111-e063-6294a90ab4b7 2025-01-06 Warnings Exact identifier application number: M020 Diaper Rash Cream Happy Cheeks DIAPER RASH HAPPY CHEEKS Dimples Bath Co. LLC 26cef2eb-a133-11ec-e063-6394a90a0f08 2025-01-06 Warnings Exact identifier application number: M020 New Kid on the Block ZINC OXIDE Dimples Bath Co. LLC 26fec959-c234-6692-e063-6394a90a6600 2025-01-06 Warnings Exact identifier application number: M020 New Kid on the Block ZINC OXIDE Dimples Bath Co. LLC 26f85758-820f-3f73-e063-6294a90a289d 2025-01-06 Warnings Exact identifier application number: M020 Bondi Sands SPF 60 Sunny Spritz Face Mist HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE BONDI SANDS (USA) INC. 2b0f0b56-233f-4c6a-e063-6394a90aea6f 2025-01-06 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