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 56 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UNME SOULMA CENTELLA and BEEF TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ZINC OXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACIDShenzhen Jufeng Qiyuan Trading Co., Ltd.4c1a3345-58c1-93c8-e063-6394a90a865e2026-03-03WarningsExact identifier
application number: M020
Botnia Gentle Sun SPF 30ZINC OXIDEBotnia, Inc005d0245-fe53-47e5-888b-683f58cd6d262026-03-03WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.64534ec3-396c-4c11-9ec1-e2615f7e24b12026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.9b7249e4-4c1f-40e7-a657-d40c53d9317f2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenSUNSCREENOld East Main Co.1673b8b1-08ad-40a5-8180-93333a8edb672026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.32036e41-2414-4498-8e1c-61511abf7a322026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 100AVOBENZONE HOMOSALATE OCTISALATEOld East Main Co.42266fa5-5f30-2a9f-e063-6394a90a1dfe2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAmazon.com Services LLCd4b4ebac-c6c2-474b-afc6-b80b8431e90f2026-03-03Warnings, Adverse reactionsExact identifier
application number: M020
Fruit Snack SPF 15 Broad Spectrum Lip BalmFRUIT SNACK SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inc24c2a9fc-892b-c74d-e063-6394a90af62c2026-03-03WarningsExact identifier
application number: M020
Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4c231aa1-75eb-c171-e063-6294a90a8b8b2026-03-03WarningsExact identifier
application number: M020
SPF 30 Mineral SunscreenZINC OXIDESmalls Brand LLC DBA Roe Wellness4c25b4ec-b045-7066-e063-6294a90ab8012026-03-03WarningsExact identifier
application number: M020
Good Weather Skin Daily Lip Sun Gloss SPF 30 Iced CoffeeZINC OXIDEGood Weather Inc.4c261e88-7f37-2361-e063-6294a90aa6022026-03-03WarningsExact identifier
application number: M020
Good Weather Skin All Over Sun Milk Face and Body SPF 50ZINC OXIDEGood Weather Inc.4c278acc-7cd5-0d85-e063-6394a90a3a722026-03-03WarningsExact identifier
application number: M020
Lekura - ZincDaily Natural Face Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4c2bed23-f77b-2c97-e063-6394a90a4ca52026-03-03WarningsExact identifier
application number: M020
NEOGEN DERMALOGY DAY-LIGHT PROTECTION AIRY SUNSCREEN BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEOUTIN FUTURES CO.,LTD.4ddce1f0-44a3-7e0c-e063-6294a90a3f7d2026-03-03WarningsExact identifier
application number: M020
Bephor Reviving Suncream SPF50ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, ZINC OXIDEGyeongbuk Institute of IT Convergence Industry Technology4c055b22-94e9-ff0d-e063-6394a90ab2ec2026-03-02WarningsExact identifier
application number: M020
Bath and Body Works SPF At The BeachAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c315bdb-dc33-1737-e063-6294a90a31a42026-03-02WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d02c8d-cdc8-b8d6-e063-6294a90ad9e42026-03-02WarningsExact identifier
application number: M020
SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTISALATEOld East Main Co.a460e512-f268-4941-beb6-29df10fdbb3a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Tanning Sunscreen SPF 15AVOBENZONE HOMOSALATE OCTISALATEOld East Main Co.42258ebe-e3cc-4d70-e063-6294a90a96512026-03-02Warnings, Adverse reactionsExact 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