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 59 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UV DEFENSE FACE MINERAL SPF 50ZINC OXIDEBETTER INVENTION LTD4b9a9efe-9aba-0ed0-e063-6394a90a2c6b2026-02-26WarningsExact identifier
application number: M020
MISTINE UV DEFENSE FACE SUNSCREEN SPF50AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9043-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9041-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
Rationale The Discovery Travel KitZINC OXIDERATIONALE GROUP PTY LTD0c919aea-4bd4-427e-97e7-9c153b42f4912026-02-25WarningsExact identifier
application number: M020
Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50ZINC OXIDEWindmill Health Products, LLCebfb149c-0371-4492-b03a-5fdcb78217532026-02-25WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE Protective DayAVOBENZONE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporationdea8e4c1-6a9c-44c6-abc8-6cdd50f35f492026-02-25WarningsExact identifier
application number: M020
Aura DefenseZINC OXIDEGrace and Glow MD LLC4ba75eff-74ef-278b-e063-6394a90a8ef02026-02-25WarningsExact identifier
application number: M020
AM Shield plusZINC OXIDEGrace and Glow MD LLC4ba7c282-c68e-8719-e063-6394a90a38142026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4babe2ab-c5da-9a83-e063-6294a90aee4c2026-02-25WarningsExact identifier
application number: M020
Daily Facial Moisturizer SPF 25SUNSCREENPerson and Covey6b9258e4-c7c6-765e-e053-2991aa0a9f4e2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac1c33-36fe-8d29-e063-6394a90a32a52026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac5550-c45f-a738-e063-6394a90ae5c82026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baca374-7aaa-8d1d-e063-6394a90a5a552026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bad1502-bc44-54ec-e063-6294a90ace8b2026-02-25WarningsExact identifier
application number: M020
Truskin SPF 30 Mineral Sunscreen Facial SerumZINC OXIDEAllure Labs2e20c132-8a03-1d5d-e063-6394a90ad2c32026-02-25WarningsExact identifier
application number: M020
Rationale The Brilliance Tinted Serum SPF 50ZINC OXIDERATIONALE GROUP PTY LTD5c38506b-1533-435f-87a6-0452bae5b29f2026-02-24WarningsExact identifier
application number: M020
FULLY RICE CERAMIDE MOISTURE SUNSCREENZINC OXIDEAdapt Inc.d8bfe222-3184-4c98-9876-ef5ac81772b62026-02-24WarningsExact identifier
application number: M020
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact 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