FDA.reportPublic FDA data

Hydra Finish SPF 15

Product NDC
54181-006
11-digit product format
541810006
Labeler code
54181
Product ID
54181-006_5b1ce64a-c6e2-52bd-e063-6394a90a3abd
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTINOXATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Guinot
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-22
Marketing end
2027-02-01
Substance
HOMOSALATE; OCTINOXATE
Active strength
40; 60 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 Finish SPF 15

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE40 mg/mL
OCTINOXATE60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4047e8ec-834a-41e6-a144-5649a7718de4Available 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
54181-006-30Hydra Finish SPF 151 in 1 CARTONCREAM110
54181-006-30Hydra Finish SPF 1530 mL in 1 TUBECREAM3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54181-006HYDRA FINISH SPF 15 (HOMOSALATE, OCTINOXATE) CREAM [GUINOT]9Current NDC, Legacy NDC, 2 package rows20240327_4047e8ec-834a-41e6-a144-5649a7718de4.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 141 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddc3d7-76df-3344-e063-6294a90a65ae2025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddf80c-8496-0f47-e063-6394a90afc182025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30dfa973-3217-1e18-e063-6294a90a8d412025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30df0039-4dc1-7355-e063-6394a90ae8002025-12-09WarningsExact identifier
application number: M020
Advanced Lip GuardTITANIUM DIOXIDE, ZINC OXIDEADVANCED DERMATOLOGY32e66ff3-ae1a-4a2a-e063-6294a90a79632025-12-09Exact identifier
application number: M020
Skin Tone Defender 20% Zinc OxideZINC OXIDECali Skin Care LLC308c711d-4c3e-1208-e063-6394a90a9cc22025-12-09WarningsExact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEADVANCED DERMATOLOGY32d781ca-7993-9875-e063-6294a90a5c262025-12-09Exact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEAdvanced Dermatology32e6c080-6ce3-8d99-e063-6294a90ac1bc2025-12-09Exact identifier
application number: M020
StriVectin multi-action Super-C SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.b299df12-fbdd-437b-9bfa-4846e361725a2025-12-09WarningsExact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f1e019-32c4-b733-e063-6394a90aca282025-12-09Exact identifier
application number: M020
RADIANCEZINC OXIDEL.S. MOORE LLC37f254cb-9de5-8f67-e063-6294a90a4e282025-12-09Exact identifier
application number: M020
StriVectin Advanced Retinol Daily Repair Moisturizer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.cfbdbba8-a739-fd32-e053-2a95a90a6f312025-12-09WarningsExact identifier
application number: M020
Hint of TintZINC OXIDEL.S. MOORE LLC37f20c14-070e-4f86-e063-6294a90ad4c22025-12-09Exact identifier
application number: M020
Hint of TintZINC OXIDEL.S. MOORE LLC37f330a0-790a-1656-e063-6294a90a691c2025-12-09Exact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f2e363-e85f-f601-e063-6294a90ab1202025-12-09Exact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL MOORE AESTHETICS37f1ac8c-3bfb-10da-e063-6294a90a8ca82025-12-09Exact identifier
application number: M020
RoC Multi Correxion Revive and Glow Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare40d4cfeb-fb00-801e-e063-6394a90ada6b2025-12-09WarningsExact identifier
application number: M020
RADIANCEZINC OXIDEL.S. MOORE LLC37f2b104-0213-c88c-e063-6294a90a42472025-12-09Exact identifier
application number: M020
Mineral Sunscreen Moisturizing Lightly TintedZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC3350c673-2afd-a00a-e063-6294a90aa1962025-12-09Exact identifier
application number: M020
Mineral Sunscreen Dry Touch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC334ffc49-3196-0995-e063-6394a90ad5592025-12-09Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54181-006-30541810006301 TUBE in 1 CARTON (54181-006-30) / 30 mL in 1 TUBE1 tube2016-07-222027-02-01NoNoCurrent