FDA.reportPublic FDA data

Vacation by Vacation Scent and Shimmer Duo

Manufacturer
Vacation Inc. | Bell International | Oxygen
Effective date
2024-05-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:13:14

Label at a glance#

ProductVacation by Vacation Scent and Shimmer Duo
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from ...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (2.9%), Homosalate (5.0%), Octisalate (4.9%), Octocrylene (8.0%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product, keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Argania Spinosa (Argan) Kernel Oil, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, Calcium Sodium Borosilicate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Dimethicone, Ethyl Ferulate, Fragrance, Hyaluronic Acid, Iron Oxides, Mica, Musa Sapientum (Banana) Fruit Extract, Neopentyl Glycol Diethylhexanoate, Palmitoyl Tripeptide-1, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Titanium Dioxide, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distributed by Vacation Inc.
936 SW 1st Ave #888 Miami, FL 33130

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

"VACATION" by Vacation®

SCENT & SHIMMER DUO

1.7 FL OZ (50 ML) EAU DE TOILETTE + 2.9 FL OZ (86 ML) SHIMMER OIL SPF 30

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-015-15Vacation by Vacation Scent and Shimmer Duo86 mL in 1 BOTTLEOIL86 mL8 g in 100mL3
80641-203-01Vacation by Vacation Scent and Shimmer Duo1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-015VACATION BY VACATION SCENT AND SHIMMER DUO (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) KIT [VACATION INC.]3Current NDC20240601_aef8388f-84bb-4e2b-8ae2-aa64f415a632.zip
80641-203VACATION BY VACATION SCENT AND SHIMMER DUO (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) KIT [VACATION INC.]3Current NDC, 2 package rows20240601_aef8388f-84bb-4e2b-8ae2-aa64f415a632.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80641-20380641-203-01
80641-01580641-015-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
ARGAN OIL4V59G5UW9XIACT
LEVOMENOL24WE03BX2TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SHEANUT OILO88E196QRFIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
COCONUT OILQ9L0O73W7LIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYL FERULATE5B8915UELWIACT
HYALURONIC ACIDS270N0TRQYIACT
FERRIC OXIDE RED1K09F3G675IACT
MICAV8A1AW0880IACT
BANANA4AJZ4765R9IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
SCLEROCARYA BIRREA SEED OILWDO4TLS35FIACT
JOJOBA OIL724GKU717MIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ALCOHOL3K9958V90MINGR
WATER059QF0KO0RINGR

Source Document#

Source XML

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.0c4e6fa1-c78d-4f9d-969f-135d4ed67daf2026-03-30WarningsExact identifier
ndc (package): 80641-015-15
ndc11 (package): 80641001515
Shimmer OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc.131c63ba-57fc-9ce8-e063-6294a90acd922025-04-18WarningsExact identifier
ndc (package): 80641-015-15
ndc (product): 80641-015
ndc11 (package): 80641001515
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.aef8388f-84bb-4e2b-8ae2-aa64f415a6322024-05-28WarningsExact identifier
ndc (package): 80641-015-15
ndc (package): 80641-203-01
ndc (product): 80641-203
ndc11 (package): 80641001515
ndc11 (package): 80641020301
spl id: cc0a75e5-d1b5-4472-94df-edad101d7c9d
spl set id: aef8388f-84bb-4e2b-8ae2-aa64f415a632

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.