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 85 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Dose Bioretinol Mineral SPF 40ZINC OXIDESupergoop, LLCeb5bbc70-dbdf-06a8-e053-2995a90a66c12026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Body SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCec1c30bd-76e1-9d00-e053-2a95a90a17592026-01-09WarningsExact identifier
application number: M020
Glow Screen SPF 40AVOBENZONE, OCTISALATE, OCTOCYLENESupergoop, LLC21569637-332a-461b-bf6c-33af6a83a1552026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 - DawnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf07145d5-b74d-7757-e053-2a95a90ac4c02026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 -SunsetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf7e493da-8fc6-191d-e053-6294a90aa4832026-01-09WarningsExact identifier
application number: M020
Supergoop Glow Screen SPF 40 Shade 2 Golden HourBROAD SPECTRUM SUNSCREENSupergoop LLCd2928dd7-a813-4929-e053-2a95a90aaeb42026-01-09WarningsExact identifier
application number: M020
Superscreen Hydrating Daily Cream SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCff0e4e97-8f01-bd36-e053-6394a90a47ae2026-01-09WarningsExact identifier
application number: M020
Lipshade SPF 30 Hey YallZINC OXIDESupergoop, LLCf93dfa13-ff18-ee38-e053-6394a90aea462026-01-09WarningsExact identifier
application number: M020
Triple Prep SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATESupergoop, LLC004df4e5-dba9-6030-e063-6394a90a76d32026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC12605fb4-0de6-94f3-e063-6294a90a3a6f2026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Stick SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC2735c5c7-a4ef-33c3-e063-6294a90abf972026-01-09WarningsExact identifier
application number: M020
PLAY Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONESupergoop LLC2860d42c-d644-8b5a-e063-6394a90aec102026-01-09WarningsExact identifier
application number: M020
PLAY Mineral SPF 30 with Green AlgaeZINC OXIDESupergoop LLC29a1ff4b-3875-5275-e063-6394a90a53fd2026-01-09WarningsExact identifier
application number: M020
Every. Single. Face. Watery SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCd086a9b8-19e5-f713-e053-2995a90aa9762026-01-09WarningsExact identifier
application number: M020
3D Tinted Moisturizing BS SPF 30ZINC OXIDEAllure Labs47fd415f-819e-bbb8-e063-6394a90a2c6a2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE BODY SUNSCREEN SPF50SUNCARE BODY SUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.4801cfd2-1fe2-d118-e063-6294a90a6c8b2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
application number: M020
RODAN and FIELDS ENHANCEMENTS MEDIUMTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC6aa6ad3f-2c52-4031-9e6c-7526c42de71d2026-01-09WarningsExact identifier
application number: M020
FACE SPF 47 SETTINGFACE SPF 47 SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47db9a54-c02f-d2ea-e063-6394a90ab9732026-01-08WarningsExact identifier
application number: M020
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact 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