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 28 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ILIA SUPER SERUM SKIN TINT (ST11 MATIRA)ZINC OXIDEIlia, Inc.b595b5f0-dd3d-79ef-e053-2a95a90ad9fb2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST10 PORTO FERRO)ZINC OXIDEIlia, Inc.b595a378-3285-bea2-e053-2995a90aedbf2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST15 PORTO COVO)ZINC OXIDEIlia, Inc.b595db16-796c-726f-e053-2995a90ab7832026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST2 TULUM)ZINC OXIDEIlia, Inc.b5939cc9-4eab-5f73-e053-2995a90a7a7b2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST8 SHELA)ZINC OXIDEIlia, Inc.b5956413-af6b-11bd-e053-2a95a90a90472026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST9 PALOMA)ZINC OXIDEIlia, Inc.b5959358-0d93-aa37-e053-2995a90acdae2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST1 RENDEZVOUS)ZINC OXIDEIlia, Inc.b592225c-904e-350a-e053-2a95a90adc2b2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST7 DIAZ)ZINC OXIDEIlia, Inc.b5954732-66d7-53db-e053-2995a90a2a3b2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST4 FORMOSA)ZINC OXIDEIlia, Inc.b594d426-a79e-19e9-e053-2995a90aa6652026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST3 BALOS)ZINC OXIDEIlia, Inc.b594bc81-d164-bda7-e053-2995a90a69ad2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST18 MALI)ZINC OXIDEIlia, Inc.b59608e6-a407-75dc-e053-2995a90a25cf2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST19 LOVINA)ZINC OXIDEIlia, Inc.b9805c9c-0513-2386-e053-2995a90a21852026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST5 BOM BOM)ZINC OXIDEIlia, Inc.b594f910-f1bc-2bcf-e053-2995a90aebee2026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST17.5 PERISSA)ZINC OXIDEIlia, Inc.b9805059-583d-e3da-e053-2a95a90a4f652026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST14.5 HONOPU)ZINC OXIDEIlia, Inc.b9803596-c090-463f-e053-2a95a90a02342026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST6.5 KAI)ZINC OXIDEIlia, Inc.b97f5589-069d-7e93-e053-2a95a90a19a92026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST12.75 PAPAKOLEA)ZINC OXIDEIlia, Inc.b97fa903-4a0f-064e-e053-2a95a90a1c612026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST16.5 JARDIN)ZINC OXIDEIlia, Inc.b980155b-98f1-6460-e053-2a95a90a58a22026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST13.5 RIALTO)ZINC OXIDEIlia, Inc.b97fadb3-fa6e-26b0-e053-2a95a90abfd52026-05-21WarningsExact identifier
application number: M020
ILIA SUPER SERUM SKIN TINT (ST9.5 BAIKAL)ZINC OXIDEIlia, Inc.b97f7fe9-c06e-7c11-e053-2a95a90a6a6d2026-05-21WarningsExact 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