FDA.reportPublic FDA data

VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN

Manufacturer
Vacation Inc.
Effective date
2024-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:10:30

Label at a glance#

ProductVACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure9 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 (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%)

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

Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, C12-15 Alkyl Benzoate, Caprylic/ Capric Triglyceride, Fragrance, Methyl Dihydroabietate, Octyldodecanol, Passiflora Edulis (Passionfruit) Seed Oil, Phenoxyethanol, Sclerocarya Birrea (Marula) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Vitis Vinifera (Chardonnay Grape) Seed Oil, VP/Hexadecene Copolymer

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 - 100 ML Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vacation®

Chardonnay Oil
BROAD SPECTRUM SPF 30 SUNSCREEN OIL

Chardonnay Seed Sunscreen Oil
by The Eternal Vacation® of Miami
"Clean, Lightweight & Refreshing"
"For an Enviable Shine"

SPF 30

3.4 FL OZ / 100 ML

PRINCIPAL DISPLAY PANEL - 100 ML Bottle Label
PRINCIPAL DISPLAY PANEL - 100 ML Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80641-003-012024-02-29C16284748780-11030e365-03d9-111a-e063-dadaa90a10e2VACATION ® CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN
80641-003-022024-02-29C16284748780-11030e365-03d9-111a-e063-dadaa90a10e2VACATION ® CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN
80641-003-012024-01-30C16284748780-11030e365-03d9-111a-e063-dadaa90a10e2VACATION ® CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN
80641-003-022024-01-30C16284748780-11030e365-03d9-111a-e063-dadaa90a10e2VACATION ® CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-003VACATION CHARDONNAY BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) OIL [VACATION INC.]4Legacy NDC20240302_11d5f618-98eb-4da0-9535-e068bc0c2d04.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80641-00380641-003-01, 80641-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Levomenol24WE03BX2TIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Sheanut OilO88E196QRFIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Methyl Dihydroabietate7666FJ0J9FIACT
Octyldodecanol461N1O614YIACT
Passiflora Edulis Seed OilF3VOA31UHQIACT
PhenoxyethanolHIE492ZZ3TIACT
SCLEROCARYA BIRREA SEED OILWDO4TLS35FIACT
Jojoba Oil724GKU717MIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
Vinylpyrrolidone/Hexadecene CopolymerKFR5QEN0N9IACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
45fe9fb1-0019-75cf-e063-6394a90aba3811d5f618-98eb-4da0-9535-e068bc0c2d042025-12-15WarningsExact identifier
spl set id: 11d5f618-98eb-4da0-9535-e068bc0c2d04

Reported adverse events (FAERS/openFDA)#

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