FDA.reportPublic FDA data

KONEUK SUNSCREEN SPF50

Product NDC
84167-323
11-digit product format
841670323
Labeler code
84167
Product ID
84167-323_48dd7f6e-2a4e-2c92-e063-6294a90a4255
Type
HUMAN OTC DRUG
Nonproprietary name
KONEUK SUNSCREEN SPF50
Dosage form
CREAM
Route
CUTANEOUS
Labeler
Guangzhou Meixi Biotechnology Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-21
Substance
OCTOCRYLENE; HOMOSALATE; TITANIUM DIOXIDE; AVOBENZONE; ENSULIZOLE
Active strength
1; 1; 1; 1; 1 g/1; g/1; g/1; g/1; g/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
KONEUK SUNSCREEN SPF50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE1 g/1
HOMOSALATE1 g/1
TITANIUM DIOXIDE1 g/1
AVOBENZONE1 g/1
ENSULIZOLE1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
15FIX9V2JPInternal UNII lookup
G63QQF2NOXInternal UNII lookup
9YQ9DI1W42Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48dd7f6e-2a4d-2c92-e063-6294a90a4255Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84167-323-03KONEUK SUNSCREEN SPF505 in 1 BOXCREAM51
84167-323-03KONEUK SUNSCREEN SPF501 in 1 BOTTLECREAM11

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 161 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BANANA BOATAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC236d2dce-70aa-66d2-e063-6394a90aff522025-11-17WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Dusky Pink 8gZINC OXIDENAKED SUNDAYS PTY LTD2f441311-b41c-d4e8-e063-6394a90a697a2025-11-17WarningsExact identifier
application number: M020
Woro Beauty SPFortlessTITANIUM DIOXIDE, ZINC OXIDEWoro Beauty3d86ef02-c947-2791-e063-6394a90a42cc2025-11-17WarningsExact identifier
application number: M020
Dolce Glow Body BalmZINC OXIDEDolce Glow, Inc.43cea601-a6c0-4de3-e063-6294a90aa8eb2025-11-17WarningsExact identifier
application number: M020
Hello Sunday The One For Your Lips Clear Lip Balm SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c92dfc3-782d-e11f-e063-6394a90a2f8a2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 33WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d506dd-4103-de3c-e063-6294a90ac1902025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d5174f-6bd2-1294-e063-6294a90a407b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d5299f-6273-30ab-e063-6294a90a082e2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d53bac-560d-6e4d-e063-6394a90a40c42025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d55c3d-4550-8131-e063-6394a90a0eed2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43d56169-4843-8546-e063-6294a90a8a102025-11-17WarningsExact identifier
application number: M020
BRING GREEN TEA TREE CICA SUN CUSHIONZINC OXIDE, TITANIUM DIOXIDECJ Olive Young Corporation30850a56-6438-dbe1-e063-6294a90a6d9f2025-11-17WarningsExact identifier
application number: M020
BRING GREEN TEA TREE CICA SUNCREAMZINC OXIDECJ Olive Young Corporation30bdb3c6-2bfa-87c2-e063-6394a90a9a432025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c73747-82b6-c71c-e063-6294a90aea522025-11-17WarningsExact identifier
application number: M020
Arnies Mineral Sunscreen - Broad Spectrum SPF 50 with Zinc OxideZINC OXIDEGimmie Botanicals LLC43e24a9a-a25c-f011-e063-6394a90abbb22025-11-17WarningsExact identifier
application number: M020
Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Pink Pop 8gZINC OXIDENAKED SUNDAYS PTY LTD2f46049b-7e81-9c7e-e063-6394a90a8f492025-11-14WarningsExact identifier
application number: M020
Huey Daily MineralTITANIUM DIOXIDE, ZINC OXIDEHuey15bdf9c6-3bfa-4eef-e063-6294a90a195f2025-11-14WarningsExact identifier
application number: M020
Pipette Diaper RashZINC OXIDEPipette LLC2a93998c-1855-9207-e063-6294a90ab0e92025-11-14WarningsExact identifier
application number: M020
Ware Sonny UniversalTITANIUM DIOXIDE, ZINC OXIDEWare Cosmeticsfe2b9d16-9215-e21e-e053-6394a90a51562025-11-14WarningsExact identifier
application number: M020
YAY NOVELTY ALL-IN-ONETITANIUM DIOXIDE, ZINC OXIDEYAY Noveltyfb833158-d0d8-de7f-e053-6294a90adc5a2025-11-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84167-323-03841670323035 BOTTLE in 1 BOX (84167-323-03) / 1 CREAM in 1 BOTTLE5 bottle2026-01-21NoNoCurrent