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 182 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0436b-85b6-5099-e063-6294a90a4c2e2025-10-09WarningsExact identifier
application number: M020
CoreTex Professional Outdoor Skin Protection WalletCORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLETCoreTex Products Incf57bc089-405b-cdcd-e053-2995a90a9d122025-10-09WarningsExact identifier
application number: M020
Mist Me SPF-40ZINC OXIDECove Suncare LLCb7f09089-54a4-4f60-b632-e3f4321313ec2025-10-09WarningsExact identifier
application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 35 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.29817fdc-f14c-4013-a8ed-4367f3b2867c2025-10-09WarningsExact identifier
application number: M020
Skinny Dip SPF-50ZINC OXIDECove Suncare LLC7bef2966-9351-4ea6-aeed-0d568376d86b2025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0f0ba2e9-126f-13c0-e063-6394a90aa6a42025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC08997bd4-d6b9-fffc-e063-6294a90a77ae2025-10-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLC75f81b2d-cabc-443f-b4b5-76bd2321826b2025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC1390f863-709e-412b-9a25-b65217844e442025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCccc2e40b-5301-4055-8a89-47366687cfb72025-10-08WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC0f0dd2e4-3dda-c872-e063-6294a90a20a32025-10-08WarningsExact identifier
application number: M020
ScalpHair MistSunscreen SPF30COOLA SCALPHAIR MIST ORGANIC SUNSCREEN SPF30COOLA LLCc7d2098f-6fdf-68e5-e053-2a95a90a18982025-10-08WarningsExact identifier
application number: M020
Block Party SPF-50ZINC OXIDECove Suncare LLC24ffb6ec-d922-40c0-b325-c15f8433027a2025-10-08WarningsExact identifier
application number: M020
Sun Kids mineral BLUEBERRY SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDEThe Natural SKN Company40945805-6f2e-74a1-e063-6394a90a04a32025-10-07WarningsExact identifier
application number: M020
ProtecTINT 10NHOMOSALATE, OCTISALATE, ZINC OXIDESupergoop, LLC0801287f-0df5-4303-e063-6394a90a503b2025-10-07WarningsExact identifier
application number: M020
Vertra Pearl White Face Stick SPF 50PADIMATE O, TITANIUM DIOXIDEEai-jr 286, Incb69a75e0-8724-35ae-e053-2a95a90a5f342025-10-07WarningsExact identifier
application number: M020
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEEAI-JR 286, Inc.b9ea12e8-6ed9-d805-e053-2a95a90aa1072025-10-07WarningsExact identifier
application number: M020
SPF50 SunscreenSUNSCREENKINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTDb3cde609-7d62-2ac7-e053-2a95a90a26b32025-10-07Exact identifier
application number: M020
Summer Face Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESUMMER GELEE LLCfe256ff4-cb92-4262-8ab9-7cc912e0af222025-10-06WarningsExact identifier
application number: M020
Sun Veil Broad Spectrum SPF50ZINC OXIDEMONAT GLOBAL CORP3ba28de7-74a2-5cde-e063-6394a90add262025-10-06WarningsExact 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