FDA.reportPublic FDA data

HYDRA BEAUTE SPF 15

Product NDC
54181-009
11-digit product format
541810009
Labeler code
54181
Product ID
54181-009_5b1ceef6-edfc-56ad-e063-6394a90a9e21
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
Guinot
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-01
Marketing end
2027-02-01
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE
Active strength
28.5; 50; 70; 30; 90 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
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
HYDRA BEAUTE SPF 15

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE28.5 mg/mL
HOMOSALATE50 mg/mL
OCTINOXATE70 mg/mL
OCTISALATE30 mg/mL
OCTOCRYLENE90 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal 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
806d1e18-a3fc-43df-a52a-a640902d0887Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54181-009-50HYDRA BEAUTE SPF 151 in 1 BOXCREAM15
54181-009-50HYDRA BEAUTE SPF 1550 mL in 1 TUBECREAM505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54181-009HYDRA BEAUTE SPF 15 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE) CREAM [GUINOT]4Current NDC, Legacy NDC, 2 package rows20231020_806d1e18-a3fc-43df-a52a-a640902d0887.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 67 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
application number: M020
SHISEIDO FUTURE LX UNIVERSAL DEFENSE SOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION0a6f8eef-48e9-44f5-9811-629bc0dc07d02026-01-28WarningsExact identifier
application number: M020
Hampton Sun SPF 45 Tinted FaceHOMOSALATE 10% OCTOCRYLENE 6% AVOBENZONE 3%S&C Hampton Sun LLC0fc0f2c7-ec0f-4976-9872-82a6bfe8b46b2026-01-28WarningsExact identifier
application number: M020
Walgreens 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49775d1a-e573-a596-e063-6294a90a7cf62026-01-28WarningsExact identifier
application number: M020
AVON ANEW ULTIMATE MULTI-PERFORMANCE DAY BROAD SPECTRUM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONEThe Avon Company49784430-2ffe-0cbb-e063-6394a90adb232026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3f2f90f1-28dd-48e8-9083-ea04815acc6b2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 30 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCbaf32d84-4db5-4ed0-9814-5470b7d1f4a42026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 15AVOBENZONE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 50 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCdc33d9e8-3463-485d-a1ee-6319ed91454c2026-01-28WarningsExact identifier
application number: M020
ALOE ICE SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCe4b861d2-3680-4ed7-8650-d1d839da5ab22026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC1bf1635a-825e-417f-97b4-4bce6d251d192026-01-28WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE 20%The Daily Suncare LLC, DBA Daily Shade1a392f6b-1bb1-c49d-e063-6294a90a791d2026-01-28WarningsExact identifier
application number: M020
KIZO LAB UV DEFENSE CLEAR SUNSCREN SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEYB CHEMIA LLC0053ae49-b9a1-c3f4-e063-6394a90abcb82026-01-28WarningsExact identifier
application number: M020
Orange GelAVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATEVacation Inc.132896ef-d6c6-4ec7-e063-6294a90a103b2026-01-28WarningsExact identifier
application number: M020
REDEFINE Triple DefenseAVOBENZONE, OCTISALATE, OCTOCRYLENERodan & Fieldsd1dd62c6-33ac-4941-ab99-9eb8cc3c208a2026-01-27WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e11009-ffcb-dd59-e063-6294a90add222026-01-27WarningsExact identifier
application number: M020
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M020
ONSART Mineral Sunscreen SPF 50ZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.495e3266-a59f-42f7-e063-6394a90adfa32026-01-27WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC54868d6f-ae4c-476d-8c77-c4a72b13d2ea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 Sunscreen Shimmer Sunscreen Mist For the FaceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCdd036e0c-0c27-42b3-9d2c-33839a8631f92026-01-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54181-009-50541810009501 TUBE in 1 BOX (54181-009-50) / 50 mL in 1 TUBE1 tube2019-01-012027-02-01NoNoCurrent