FDA.reportPublic FDA data

Biore UV Aqua Rich

Product NDC
10596-198
11-digit product format
105960198
Labeler code
10596
Product ID
10596-198_50885143-a3f1-d324-e063-6294a90a9bba
Type
HUMAN OTC DRUG
Nonproprietary name
OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE
Dosage form
LIQUID
Route
TOPICAL
Labeler
KAO USA
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-10
Substance
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
5; 5; 10; 3 g/100mL; g/100mL; g/100mL; g/100mL
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
Biore UV Aqua Rich
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE5 g/100mL
OCTOCRYLENE5 g/100mL
HOMOSALATE10 g/100mL
AVOBENZONE3 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal 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
2bc23bb5-86bb-7915-e063-6394a90a9d72Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-198-17Biore UV Aqua Rich1 in 1 BOXLIQUID11
10596-198-17Biore UV Aqua Rich50 mL in 1 TUBELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-198BIORE UV AQUA RICH (OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE) LIQUID [KAO USA]1Current NDC, 2 package rows20250121_2bc23bb5-86bb-7915-e063-6394a90a9d72.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 240 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sunbetter Broad Spectrum SPF 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Kiss Lip Balm Coconut CrushAVOBENZONE, HOMOSALATE, OCTOCRYLENEBONDI SANDS (USA) INC.2b142875-d413-aebe-e063-6394a90aaca02025-01-06WarningsExact identifier
application number: M020
glo SKIN BEAUTY Oil Free SPF 40GLO SKIN BEAUTY OIL FREE SPF 40Hayden Caleel LLC6b27a508-8669-418f-bcb2-61a35b79a3a82025-01-05WarningsExact identifier
application number: M020
glo SKIN BEAUTY Luminous Liquid Foundation SPF 18GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18Hayden Caleel LLCdd863361-281d-45fe-a8c1-6e4c670809a52025-01-05WarningsExact identifier
application number: M020
glo Skin Beauty C-Shield Anti-Pollution Moisture Tint Broad Spectrum SPF 30GLO SKIN BEAUTY C-SHIELD ANTI-POLLUTION MOISTURE TINT BROAD SPECTRUM SPF 30Hayden Caleel LLC9dbe250b-1b88-43b7-8e24-c1f5aaba0f8d2025-01-05WarningsExact identifier
application number: M020
Wildberry Lip BalmLIP BALMCasad Company Inc.5e13dc33-67b7-4461-bec5-0c3edc72f8b42025-01-03WarningsExact identifier
application number: M020
Iced Pear Lip BalmLIP BALMCasad Company Inc.1d9a62dd-c11e-4f97-9164-edc84adbe05b2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SandalwoodZINC OXIDEEVER FAME PTE. LTD.2ace641a-b440-d0b3-e063-6394a90a86322025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SepiaZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e82d-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 TruffleZINC OXIDEEVER FAME PTE. LTD.2acf4b3b-e830-d512-e063-6294a90a3fef2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WalnutZINC OXIDEEVER FAME PTE. LTD.2acf75d2-8ad7-1bd3-e063-6294a90ac0be2025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 WheatZINC OXIDEEVER FAME PTE. LTD.2acf92a1-6d2a-5517-e063-6294a90a74882025-01-03WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 Warm VanillaZINC OXIDEEVER FAME PTE. LTD.2acf9020-c779-31c2-e063-6294a90a1ab52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad009bc-29ce-0ba6-e063-6294a90a75802025-01-03WarningsExact identifier
application number: M020
Earths Daughter Bing Cherry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad07286-f8af-7a9f-e063-6394a90a6a242025-01-03WarningsExact identifier
application number: M020
Earths Daughter Vanilla Bean SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad0db95-a283-3c91-e063-6294a90ae5232025-01-03WarningsExact identifier
application number: M020
Earths Daughter Strawberry Breeze SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad129b7-4ecd-a967-e063-6294a90ad8c42025-01-03WarningsExact identifier
application number: M020
Earths Daughter Citrus Blast SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad18f4b-4251-be82-e063-6394a90acac52025-01-03WarningsExact identifier
application number: M020
Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEarth's Daughter2ad1bb50-869e-8122-e063-6294a90ac7242025-01-03WarningsExact identifier
application number: M020
Glow Baby Brightening Setting Mist SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPacifica Beauty, LLCf2f53cf9-3717-07ff-e053-2a95a90a03fb2025-01-03WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10596-198-17105960198171 TUBE in 1 BOX (10596-198-17) / 50 mL in 1 TUBE1 tube2025-01-10NoNoCurrent