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 144 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Florida Babe SPORT Mineral Sunscreen Stick TintedTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31f5bbe4-5f6e-3bef-e063-6294a90a26462025-12-09Exact identifier
application number: M020
Florida Babe SPORT Mineral Sunscreen Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA31f54a79-70b7-def5-e063-6294a90a709b2025-12-09Exact identifier
application number: M020
Florida Babe Sport Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETichy Anesthesia PA3231b71c-4d27-e5e2-e063-6294a90a031b2025-12-09Exact identifier
application number: M020
Arbonne Soft Focus Veil Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEArbonne International, LLC3c9b605b-5a16-4f89-a956-8c4c62de72d32025-12-09WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE AESTHETICS ACADEMY, LLC364b9560-f7a1-ed8f-e063-6294a90a2c412025-12-09Exact identifier
application number: M020
Sunshield Moisturizing Sunscreen and AntioxidantZINC OXIDEOculofacial Surgery andCosmetic Laser Institute, LLC.32c247fc-d4da-e03d-e063-6394a90a72b02025-12-09Exact identifier
application number: M020
SCALP SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEFOLICULE LLC387b10e1-5443-7b7a-e063-6394a90a2c7a2025-12-09Exact identifier
application number: M020
Sunshield Moisturizing Sunscreen and AntioxidantZINC OXIDEOculofacial Surgery andCosmetic Laser Institute, LLC.32c3936e-4089-edd0-e063-6294a90ad3f82025-12-09Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDETHE AESTHETICS ACADEMY, LLC364cf1f7-1f87-51f7-e063-6294a90a789c2025-12-09Exact identifier
application number: M020
Non-Tinted Foaming Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE AESTHETICS ACADEMY, LLC3698c076-68b1-7d28-e063-6394a90a517c2025-12-09Exact identifier
application number: M020
Non-Tinted Replenishing Daily ProtectionZINC OXIDETHE AESTHETICS ACADEMY, LLC3699159a-3561-9ff6-e063-6394a90af9fd2025-12-09Exact identifier
application number: M020
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c1723-fb1d-ae3c-e063-6294a90a46092025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Satin Dewy FinishZINC OXIDETRU SKIN RITUALS3249d05b-0f5c-4787-e063-6294a90aa0d72025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c3a18-ba8f-912d-e063-6394a90a24472025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c8641-1161-b8ac-e063-6394a90ae4512025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Silk Matte FinishTITANIUM DIOXIDE, ZINC OXIDETRU SKIN RITUALS3248eb22-1e10-2091-e063-6394a90ad3e12025-12-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325cce54-a885-d586-e063-6394a90a90db2025-12-09Exact identifier
application number: M020
Sheer Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDETRU SKIN RITUALS324acd75-9c38-4adc-e063-6394a90afa122025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Satin Dewy FinishZINC OXIDETRU SKIN RITUALS324960e6-c1e7-d2b9-e063-6294a90a92ce2025-12-09Exact identifier
application number: M020
Sol Purpose Mineral Sunscreen TintedZINC OXIDETRU SKIN RITUALS324a3475-07f0-033c-e063-6394a90a811a2025-12-09Exact 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