VACATION LIP BALM- avobenzone, homosalate, octisalate, and octocrylene gel

Vacation Lip Balm by

Drug Labeling and Warnings

Vacation Lip Balm by is a Otc medication manufactured, distributed, or labeled by Vacation INC., Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Uses

• Helps prevent sunburn and chapped lips.

Warnings

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

• Stop use if rash occurs.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

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

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

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

PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton

Vacation®

BROAD SPECTRUM
SPF 30 LIP BALM
SUNSCREEN

NET WT 0.5 OZ / 15 ML

INGREDIENTS AND APPEARANCE

VACATION LIP BALM 
avobenzone, homosalate, octisalate, and octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80641-720
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	3 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	4 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate (UNII: 8N725H4EFN)
Diisostearyl Malate (UNII: QBS8A3XZGQ)
Polybutene (1400 MW) (UNII: 1NA5AO9GH7)
Shea Butter (UNII: K49155WL9Y)
Microcrystalline Wax (UNII: XOF597Q3KY)
Ethylhexyl Cocoate (UNII: I1MPW273QS)
Octyldodecanol (UNII: 461N1O614Y)
Polyglyceryl-2 Diisostearate (UNII: DG195GP57P)
Synthetic Wax (1200 MW) (UNII: Q3Z4BCH099)
Disteardimonium Hectorite (UNII: X687XDK09L)
Astrocaryum Murumuru Seed Butter (UNII: 12V64UPU6R)
Vanillin (UNII: CHI530446X)
Coconut Oil (UNII: Q9L0O73W7L)
Propylene Carbonate (UNII: 8D08K3S51E)
.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Soybean Oil (UNII: 241ATL177A)
Sunflower Oil (UNII: 3W1JG795YI)
Titanium Dioxide (UNII: 15FIX9V2JP)
Saccharin Sodium Anhydrous (UNII: I4807BK602)
Ethylene Brassylate (UNII: 9A87HC7ROD)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
Banana (UNII: 4AJZ4765R9)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Sorbitan Monolaurate (UNII: 6W9PS8B71J)
C18-36 Acid Triglyceride (UNII: ZRA72DR3R7)
Palmitoyl Tripeptide-1 (UNII: RV743D216M)
Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80641-720-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	03/15/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	03/15/2026

Labeler - Vacation INC. (117644631)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	MANUFACTURE(80641-720)