FDA.reportPublic FDA data

Biore Aqua Rich UV

Product NDC
10596-197
11-digit product format
105960197
Labeler code
10596
Product ID
10596-197_2ee5d157-7544-fefe-e063-6294a90ad385
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
2023-04-10
Substance
HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
7; 3; 5; 5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Aqua Rich UV
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE7 g/100mL
AVOBENZONE3 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9024581-dbab-b7cb-e053-6294a90a8b9aAvailable 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
10596-197-17Biore Aqua Rich UV50 mL in 1 TUBELIQUID503
10596-197-17Biore Aqua Rich UV1 in 1 BOXLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-197BIORE AQUA RICH UV (OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE) LIQUID [KAO USA]3Current NDC, 2 package rows20250227_f9024581-dbab-b7cb-e053-6294a90a8b9a.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 180 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 IvoryZINC OXIDECosmetic Enterprises Ltd2748c351-0a7d-6913-e063-6394a90a6ef22025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 NudeZINC OXIDECosmetic Enterprises Ltd265bd73f-2509-90c6-e063-6294a90a2e192025-10-13WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCdad4b244-2d34-40cb-88dc-991358df83b02025-10-10WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeafc00ce-12e7-921f-e053-2995a90a241a2025-10-10WarningsExact identifier
application number: M020
KinesysOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc50adf1db-118f-4843-b356-e239931606732025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance FreeOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Ince0949325-7de1-4da4-82b6-8004916412a02025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d0294b-e937-336d-e063-6294a90a5c3c2025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free SunscreenOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc9adea1a4-efa6-4fe1-85e8-ed69fa098a872025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc60e7ed8e-f421-4e08-97a8-af647200e4ae2025-10-10WarningsExact identifier
application number: M020
KINeSYS Pro Sport Lip Balm with Shea Butter Broad Spectrum 30ZINC OXIDEWilc Healthcare Ince5820376-897f-4c77-aadc-7991137870b72025-10-10WarningsExact identifier
application number: M020
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45ZINC OXIDEWilc Healthcare Inc247a323f-9a08-4717-8553-ebc9c519817b2025-10-10WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d15366-85b8-f5e8-e063-6294a90a5fd82025-10-10WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4369f2f-fdc3-e48e-e053-2995a90a07f72025-10-10WarningsExact identifier
application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4ac746a-a50a-8041-e053-2a95a90a8ea62025-10-10WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEWasatch Product Development, LLC.e895d942-e50e-1ad6-e053-2995a90a0e022025-10-10WarningsExact identifier
application number: M020
Illuminating SPF 50 plus drops Broad Spectrum SunscreenZINC OXIDECosmetic Enterprise Ltd13f40485-b98e-e804-e063-6394a90af2af2025-10-10WarningsExact identifier
application number: M020
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30ZINC OXIDECosmetic Enterprises LTDa84d246b-1153-85ff-e053-2995a90a270a2025-10-10WarningsExact identifier
application number: M020
MediChoice Moisturizing Lip Balm SPF15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEO&M HALYARD, INC.00327815-28f0-4198-bca7-c8ae768ff4162025-10-09WarningsExact identifier
application number: M020
Daybird 4-in-1 Skin Tint SerumZINC OXIDEResette, Inc.19c1a934-b0f5-1068-e063-6294a90a3b1f2025-10-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10596-197-17105960197171 TUBE in 1 BOX (10596-197-17) / 50 mL in 1 TUBE1 tube2023-04-10NoNoCurrent