FDA.reportPublic FDA data

Vacation Lip Balm

Manufacturer
Vacation INC. | Oxygen Development LLC
Effective date
2026-03-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:04

Label at a glance#

ProductVacation Lip Balm
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure10 sections

Indications and uses

Helps prevent sunburn and chapped lips.

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 aging. To decrease this 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...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (3.0%), Homosalate (3.0%), Octisalate (4.0%), Octocrylene (10.0%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn and chapped lips.

Warnings

WARNINGS SECTION

  • For external use only.
  • Keep out of eyes.

OTC - STOP USE SECTION

  • Stop use if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. If swallowed, 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 aging. To decrease this 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–sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Diisostearyl Malate, Polybutene, Butyrospermum Parkii (Shea) Butter, Hydrogenated Polyisobutene, Microcrystalline Wax, Octyldodecanol, Flavor, Polyglyceryl-2 Diisostearate, Synthetic Wax, Disteardimonium Hectorite, Astrocaryum Murumuru Seed Butter, Vanillin, Cocos Nucifera (Coconut) Oil, Propylene Carbonate, Tocopheryl Acetate (Vitamin E), Hyaluronic Acid, Glycine Soja (Soybean) Oil, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Helianthus Annuus (Sunflower) Seed Oil, Sodium Saccharin, Ethylene Brassylate, Tocopherol, Musa Sapientum (Banana) Fruit Extract, C12-15 Alkyl Benzoate, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbitan Laurate, C18-36 Acid Triglyceride, C18-36 Acid Glycol Ester, Titanium Dioxide (CI 77891)

Other Information

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vacation®

BROAD SPECTRUM
SPF 30 LIP BALM
SUNSCREEN

NET WT 0.5 OZ / 15 ML

PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton
PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-720-01Vacation Lip Balm15 mL in 1 TUBEGEL151

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80641-72080641-720-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate8N725H4EFNIACT
Diisostearyl MalateQBS8A3XZGQIACT
Polybutene (1400 MW)1NA5AO9GH7IACT
Shea ButterK49155WL9YIACT
Microcrystalline WaxXOF597Q3KYIACT
Ethylhexyl CocoateI1MPW273QSIACT
Octyldodecanol461N1O614YIACT
Polyglyceryl-2 DiisostearateDG195GP57PIACT
Synthetic Wax (1200 MW)Q3Z4BCH099IACT
Disteardimonium HectoriteX687XDK09LIACT
Astrocaryum Murumuru Seed Butter12V64UPU6RIACT
VanillinCHI530446XIACT
Coconut OilQ9L0O73W7LIACT
Propylene Carbonate8D08K3S51EIACT
.Alpha.-Tocopherol Acetate, D-A7E6112E4NIACT
Hyaluronate SodiumYSE9PPT4THIACT
Soybean Oil241ATL177AIACT
Sunflower Oil3W1JG795YIIACT
Titanium Dioxide15FIX9V2JPIACT
Saccharin Sodium AnhydrousI4807BK602IACT
Ethylene Brassylate9A87HC7RODIACT
.Alpha.-TocopherolH4N855PNZ1IACT
Banana4AJZ4765R9IACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Aloe Vera LeafZY81Z83H0XIACT
Sorbitan Monolaurate6W9PS8B71JIACT
C18-36 Acid TriglycerideZRA72DR3R7IACT
Palmitoyl Tripeptide-1RV743D216MIACT
Palmitoyl Tetrapeptide-7Q41S464P1RIACT

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
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.4ba8ed52-2f52-40b9-a810-8450f9b907782026-03-10WarningsExact identifier
ndc (package): 80641-720-01
ndc (product): 80641-720
ndc11 (package): 80641072001
spl id: 3f30fa27-3289-4cab-bf11-d54fa5d05cf7
spl set id: 4ba8ed52-2f52-40b9-a810-8450f9b90778

Reported adverse events (FAERS/openFDA)#

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