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 228 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Classic Body SPF 50 Fragrance FreeAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed207afe-0b10-74c7-e053-2a95a90a9b872025-02-17WarningsExact identifier
application number: M020
Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent SunscreenOCTINOXATE, OXYBENZONE, OCTISALATEThe Avon Company2e5d6c93-f091-5388-e063-6394a90ad5602025-02-17WarningsExact identifier
application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc31a98dc7-4b99-d845-e063-6394a90a26702025-02-17WarningsExact identifier
application number: M020
Ultra sheer mineral sunscreen PRO SPF30ZINC OXIDEEden Brands Inc.2ce06566-2eb0-9a00-e063-6394a90a9ba92025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2dff0386-e151-089a-e063-6394a90a0f532025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dffc699-3b56-2c70-e063-6294a90ae2492025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
application number: M020
Coola SPF 30 Mineral Sunscreen Fragrance FreeZINC OXIDECOOLA, LLCedc6048e-0ea0-41c5-e053-2a95a90a96d92025-02-14WarningsExact identifier
application number: M020
COOLA Classic Body SPF 50 Guava MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed13afaa-35ec-8326-e053-2995a90adaf02025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
application number: M020
Sunscreen Broad Spectrum SPF 50 Vi AestheticsZINC OXIDE, OCTINOXATEVi Medical Products, INC73620765-c7c0-4bd7-82a9-00022773c9282025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2297d4-3649-a749-e063-6294a90ac2842025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e22cfde-10a1-3742-e063-6394a90ac0972025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2e5c2add-8ed0-a990-e063-6394a90a87ea2025-02-14WarningsExact identifier
application number: M020
Les Duets - Shield of Helios, sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385f75a5-6a3b-a129-e063-6394a90a52a02025-02-14WarningsExact identifier
application number: M020
Le Mieux Naked Glow Bronzer SPF 50SUNSCREENYB CHEMIA LLC46465db7-c1f0-6980-e063-6294a90a3ed82025-02-14WarningsExact identifier
application number: M020
Sheer Tint Mineral SPF Serum - Light LightZINC OXIDEMineral Fusion brandsac6fdc35-82f8-4805-875e-2aa91aedec6f2025-02-14WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 50ZINC OXIDEPeer Pharm Ltd.3989eebc-7262-4cda-84a1-ca30b638b7722025-02-13WarningsExact identifier
application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 30ZINC OXIDEPeer Pharm Ltd.8ee9f97b-9081-4e0c-aa7a-27a31cbee17a2025-02-13WarningsExact 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