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 290 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Clarity Rx Pucker Power lip plumper SPF 30 HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE Topiderm, Inc. 92504982-fe0e-404d-b7cf-f6b340b89802 2024-07-31 Warnings Exact identifier application number: M020 Essential Sheer SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 2132dc18-85ee-4449-86d2-d9f698f286c6 2024-07-31 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO tinted foaming mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, Ltd 1e78109f-4d2e-2705-e063-6294a90a5ad3 2024-07-30 Warnings Exact identifier application number: M020 Replenix Sheer SPF 50 ZINC OXIDE TITANIUM DIOXIDE Topiderm, Inc. 37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4 2024-07-29 Warnings Exact identifier application number: M020 Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATE Dr Pawpaw Limited f2628e3e-9eb0-49cb-91a6-d15c48cb8a19 2024-07-25 Warnings Exact identifier application number: M020 Thinksport Daily Face SPF 50 ZINC OXIDE thinkOperations,LLC b2422785-bd35-4248-a68f-fb4b1492a4cd 2024-07-24 Warnings Exact identifier application number: M020 Thinkbaby Clear Zinc SPF 30 ZINC OXIDE thinkOperations,LLC 7cd9c971-5556-42dc-af7b-3a88221b8c94 2024-07-24 Warnings Exact identifier application number: M020 ISNTREE ONION NEWPAIR SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE ISNTREE Inc. 0f072099-d57d-4dc4-e063-6394a90ab438 2024-07-23 Warnings Exact identifier application number: M020 ISNTREE ONION NEWPAIR SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE ISNTREE Inc. 14b11b42-d1fe-572f-e063-6394a90a9eec 2024-07-23 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxide ZINC OXIDE Fallien Cosmeceuticals, Ltd 1dda8259-4121-3c76-e063-6394a90af189 2024-07-22 Warnings Exact identifier application number: M020 Eco Lips PlantPod Sunscreen Lip Balm Sport SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Eco Lips. Inc. e64c8644-7af4-7b7f-e053-2995a90af711 2024-07-22 Warnings Exact identifier application number: M020 Thinksport SPF 30 ZINC OXIDE thinkOperations,LLC 2cecda56-4860-4d35-abc2-2bb9bdf35eae 2024-07-19 Warnings Exact identifier application number: M020 CVS Health SPORT SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE CVS PHARMACY f0e8c724-b377-5dc0-e053-2995a90a0d54 2024-07-18 Warnings Exact identifier application number: M020 EQUATE Sunscreen SPORT Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE WAL-MART STORES INC 4d819fd3-de12-4394-82f4-a48faf0b7092 2024-07-18 Warnings Exact identifier application number: M020 Big Lots Soundbody SPF 30 Ultra Sport Sunscreen AVOBENZONE HOMOSALATE OCTOCRYLENE BIG LOTS STORES, INC. f0e82a9f-17ac-b1c5-e053-2995a90ae07a 2024-07-18 Warnings Exact identifier application number: M020 Equaline SPORT Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE United Natural Foods, Inc. dba UNFI f0e8dfd4-a77c-6384-e053-2a95a90a1e4a 2024-07-18 Warnings Exact identifier application number: M020 TopCare Everyday SPORT Sun Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE TOPCO ASSOCIATES LLC f0e93aa8-1b09-1312-e053-2a95a90a7934 2024-07-18 Warnings Exact identifier application number: M020 Safeway Signature Sport Sunscreen SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE Safeway, Inc. f557a3e2-e415-1b65-e053-2995a90a987a 2024-07-18 Warnings Exact identifier application number: M020 Target Up and Up Sunscreen Sport Broad Spectrum SPF 30 AVOBENZONE HOMOSALATE OCTOCRYLENE TARGET CORPORATION bad60bc1-cf78-7a33-e053-2995a90afdc3 2024-07-18 Warnings Exact identifier application number: M020 Scar Gel SPF 35 ZINC OXIDE derma e 8cd263aa-a54b-4c55-b3e2-6f6763987d4a 2024-07-17 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