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 12 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC568083ff-0da9-7f14-e063-6394a90a43012026-07-13WarningsExact identifier
application number: M020
Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISOAVOBENZONE, HOMOSALATE, OCTISALATEKoco Life LLC3cc62c97-70c5-17f7-e063-6394a90abe252026-07-13WarningsExact identifier
application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 RoseZINC OXIDENorwex Usa, Inc.565feded-8e25-e628-e063-6294a90aee482026-07-11WarningsExact identifier
application number: M020
PoutScreen Lip Treatment Lemon MeringueAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD563e3ab9-4ee2-279c-e063-6294a90a7cf12026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWNZINC OXIDECOSMAX USA, CORPORATION5643a73d-757c-702d-e063-6294a90a2c122026-07-10WarningsExact identifier
application number: M020
INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTEZINC OXIDECOSMAX USA, CORPORATION5643d655-e335-5643-e063-6394a90a483a2026-07-10WarningsExact identifier
application number: M020
MUSELY DAYCREAM SPF40ZINC OXIDECOSMAX USA, CORPORATION56443156-3edb-a643-e063-6394a90adf9f2026-07-10WarningsExact identifier
application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40ZINC OXIDECosmax USA, Corporation56445f2d-8e5a-34eb-e063-6294a90ae26e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644854e-18d6-617d-e063-6294a90ab3e72026-07-10WarningsExact identifier
application number: M020
VERSED DAILY SUNSCREEN SPF 50HOMOSALATE, OCTISALATE, AVOBENZONECOSMAX USA, CORP5644ca1e-9032-d3fb-e063-6394a90a961e2026-07-10WarningsExact identifier
application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40ZINC OXIDECosmax USA Corporation5644855d-f864-e07b-e063-6394a90a51482026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40ZINC OXIDECOSMAX USA, CORP5644d49f-08b9-e806-e063-6294a90a80f92026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRALZINC OXIDECOSMAX USA, CORP564682e5-1051-9936-e063-6394a90abe1d2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRMZINC OXIDECOSMAX USA, CORP5646e069-5461-12c5-e063-6294a90abacb2026-07-10WarningsExact identifier
application number: M020
Protect Sport SunscreenBROAD SPECTRUM SPF 30Opal Day Spa564704f2-b26a-d737-e063-6294a90aa6ff2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRALZINC OXIDECOSMAX USA, CORP5647162a-610e-2789-e063-6294a90a75492026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVEZINC OXIDECOSMAX USA, CORP56472adb-572d-5a52-e063-6294a90a3cc32026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOLZINC OXIDECOSMAX USA, CORP56474782-beff-8437-e063-6294a90a83222026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACHZINC OXIDECOSMAX USA, CORP564749f3-e820-9003-e063-6294a90a02652026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRALZINC OXIDECOSMAX USA, CORP56477f58-3878-81fa-e063-6294a90a87b72026-07-10WarningsExact 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