FDA.reportPublic FDA data

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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct84616-005DDiscontinued by firm2026-10-27
excluded packagepackage84616-00584616-005-01DDiscontinued by firm2026-10-27
excluded packagepackage84616-00584616-005-02DDiscontinued by firm2026-10-27
excluded packagepackage84616-00584616-005-03DDiscontinued by firm2026-10-27

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
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage84616-005-03
excluded packagepackage84616-005-01
excluded packagepackage84616-005-02

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
IngredientStrength
HOMOSALATE13.5 g/100mL
OCTISALATE4.5 g/100mL
AVOBENZONE2.7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4260e410-d2d5-71b4-e063-6294a90a05b8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84616-005-01ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM50 mL in 1 TUBECREAM501
84616-005-02ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM10 mL in 1 TUBECREAM101
84616-005-03ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM2 in 1 BOXCREAM21
84616-005-04ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM60 mL in 1 TUBECREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84616-005ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [SEORIN COMPANY CO., LTD.]3Current NDC20250418_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 212 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TALLOW SUNSCREENNON-NANO ZINC OXIDEFOUNDATION COMMERCE INC363e38bf-b4b4-dcc4-e063-6294a90a5d2f2025-05-28WarningsExact identifier
application number: M020
CoreTex SunX 50 FacestickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc364989ea-c93b-d404-e063-6294a90abd092025-05-28WarningsExact identifier
application number: M020
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30OCTINOXATE, ZINC OXIDESOLVADERM LLC86dbd8c3-e95a-49a8-afe6-ff9d985e28ba2025-05-27WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350b4cce-1627-5b8f-e063-6294a90aa6bf2025-05-26WarningsExact identifier
application number: M020
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEONESKIN INC.35d57d3f-376c-2307-e063-6294a90adf512025-05-23WarningsExact identifier
application number: M020
Oathology Inzincable Lip Balm SPF 35ZINC OXIDESKINOATH LLC289a5492-af57-42e5-82af-3f1e4b369d682025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, LightZINC OXIDEALLI LLC3cb4459b-1776-414a-b5c4-0ffb9f1df7662025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, DarkZINC OXIDEALLI LLC81633684-f9ac-45cb-8a3e-f0c30b229a822025-05-22WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
application number: M020
LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230NOCTINOXATE, ZINC OXIDEBEL STAR S.A.35c106b6-9a80-01e3-e063-6294a90abc352025-05-22WarningsExact identifier
application number: M020
COSRXAIRY-LIGHT CLEAR SUNCREEN STICKCOSRX inc.313b1a73-8863-c458-e063-6394a90a01d62025-05-20WarningsExact identifier
application number: M020
Melan Antioxidant Body Mist Sunscreen SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEMELAN INC.f627b17f-d2dc-47bd-b865-08995995e8612025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB FACIAL FLUID BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.63e078a3-d5df-4458-a745-e306d734e6be2025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB DARK SPOT CORRECTOR FACIAL cream BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.90531e8f-15c6-49ac-96a4-3bdfab2bfd9b2025-05-20WarningsExact identifier
application number: M020
JAFRA BIOLAB SUNSCREENS AND CLEANSERAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.28db9f44-780f-4cd5-940e-3ee779f382472025-05-20WarningsExact identifier
application number: M020
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
application number: M020
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
application number: M020
Coola Clear California SummersOCTOCRYLENE AVOBENZONE OCTISALATE HOMOSALATECOOLA, LLC358009c4-492d-ac03-e063-6294a90af2272025-05-19WarningsExact identifier
application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEPZINC OXIDEONESKIN INC.3581f578-e19e-9ace-e063-6294a90acc342025-05-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84616-005-018461600050150 mL in 1 TUBE (84616-005-01) 50 ml2024-09-18NoNoCurrent
84616-005-028461600050210 mL in 1 TUBE (84616-005-02) 10 ml2024-12-18NoNoCurrent
84616-005-03846160005032 TUBE in 1 BOX (84616-005-03) / 60 mL in 1 TUBE (84616-005-04) 2 tube2024-12-20NoNoCurrent
84616-005-048461600050460 mL in 1 TUBE60 mlHistorical