FDA.reportPublic FDA data

Vacation SPF 50 Classic

Product NDC
80641-007
11-digit product format
806410007
Labeler code
80641
Product ID
80641-007_2ee97a94-d5a2-e05d-e063-6394a90a709b
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-01
Substance
HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
8.8; 2.9; 8.6; 4.9 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Vacation SPF 50 Classic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE8.8 g/100mL
AVOBENZONE2.9 g/100mL
OCTOCRYLENE8.6 g/100mL
OCTISALATE4.9 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2780cb5-063c-10d3-e053-2995a90a8576Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-007-01Vacation SPF 50 Classic177 mL in 1 CANSPRAY1773
80641-007-02Vacation SPF 50 Classic50 mL in 1 CANSPRAY503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-007VACATION SPF 50 CLASSIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [VACATION INC.]3Current NDC, 2 package rows20250226_f2780cb5-063c-10d3-e053-2995a90a8576.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 167 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15AVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLCe36efd74-11c2-4850-9529-1c88b7364a332025-11-12WarningsExact identifier
application number: M020
TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80minAVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLC22a40d93-ca67-4b7d-a95c-22f52cd6d2972025-11-12WarningsExact identifier
application number: M020
ZEUSZINC OXIDENEWPORT APOTHECARY, INC5354c383-08f0-4b89-b36a-96a35f47be3c2025-11-12WarningsExact identifier
application number: M020
Practical Alchemy Hydrating SPF 30ZINC OXIDEOver Here, LLC2f07df5b-dbd4-494c-a7cf-55843fb4d7c22025-11-12WarningsExact identifier
application number: M020
Dr Lift SPF 50 Mineral Sunscreen StickZINC OXIDESpa de Soleil436fdf4f-11db-7c5b-e063-6294a90a87312025-11-12WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc3676aa91-c90d-4a7a-b02e-d5b35304a04d2025-11-12WarningsExact identifier
application number: M020
HYDRATING GLOW MIST SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTDdf3bd18d-63b4-460f-bf1c-115ad35edd962025-11-11WarningsExact identifier
application number: M020
Zinka Clear Zinc Oxide SunscreenOCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONEZinka, Inc.7b097f5e-8127-49e6-8a77-4ee1fded5ff12025-11-11WarningsExact identifier
application number: M020
Total Sun ProtectionOCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDECosmed Dermaceuticals, Inc.dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f2025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF15HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC1a1c17c4-4912-4573-9f59-cbd14a014cb42025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF30HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC14f65b3d-90bf-4689-aa6e-879e06153db92025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF50HOMOSALATE, ZINC OXIDE, OCTOCRYLENEQS Key West Aloe, LLCb4fc7a51-a163-4057-8790-f2111668ec672025-11-11WarningsExact identifier
application number: M020
Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEPILLOWTALKDERM LLC30e10a62-8430-649b-e063-6394a90a97eb2025-11-11WarningsExact identifier
application number: M020
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTEDTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.279a5214-79b2-44e9-b003-378d0b9923952025-11-11WarningsExact identifier
application number: M020
Tinted Moisturizer SPF 46 Universal TintZINC OXIDE, OCTINOXATEDrmtlgy, LLC5304b568-f891-4094-9182-363ae7bcfbe42025-11-11WarningsExact identifier
application number: M020
C Lip Serum Mineral Broad Spectrum SPF 30SUNSCREENSimply Active Cosmetics323661a6-3602-1ce2-e063-6394a90a8e912025-11-10WarningsExact identifier
application number: M020
buttah Tinted Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEButtah Enterprises, LLC.43458152-0775-dd9c-e063-6394a90a61402025-11-10WarningsExact identifier
application number: M020
Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 gZINC OXIDEAspen Glow Cosmetics, LLC142eda44-76e1-7960-e063-6394a90a9ad62025-11-10WarningsExact identifier
application number: M020
TriLipiderm Broad Spectrum SPF 30BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENETriLipid Research Institute, LLC617fc696-c2a1-4855-bafb-0454e64971012025-11-10WarningsExact identifier
application number: M020
TriLipiderm Protective DayHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENETriLipid Research Institute, LLC66726c2b-27e9-5dd1-e053-2991aa0a1ba72025-11-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-007-0180641000701177 mL in 1 CAN (80641-007-01) 177 ml2022-12-01NoNoCurrent
80641-007-028064100070250 mL in 1 CAN (80641-007-02) 50 ml2025-02-24NoNoCurrent