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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone (3%), Homosalate (3%), Octisalate (4%), Octocrylene (10%)

Purpose

Sunscreen

Uses

• Helps prevent sunburn & 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 especially 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, Polyglyceryl-2 Diisostearate, Flavor, Synthetic Wax, Astrocaryum Murumuru Seed Butter, Disteardimonium Hectorite, Propylene Carbonate, Vanillin, Tocopherol (Vitamin E), Hyaluronic Acid, Ethylene Brassylate, Sodium Saccharin, Garcinia Kola Nut Extract, Prunus Avium (Sweet Cherry) Seed Oil, Caffeine, C12-15 Alkyl Benzoate, Maltodextrin, Sorbitan Laurate, C18-36 Acid Glycol Ester, C18-36 Acid Triglyceride, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Red 30 Lake (CI 73360), Red 7 Lake (CI 15850), Mica (CI 77019), Blue 1 Lake (CI 42090)

Other Information

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 15 ML Tube Carton

PEPSI

TINTED LIP GEL
SUNSCREEN

0.5 FL 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: 80641-520
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)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
Disteardimonium Hectorite (UNII: X687XDK09L)
Astrocaryum Murumuru Seed Butter (UNII: 12V64UPU6R)
Vanillin (UNII: CHI530446X)
Propylene Carbonate (UNII: 8D08K3S51E)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
D&C RED NO. 30 (UNII: 2S42T2808B)
Ethylene Brassylate (UNII: 9A87HC7ROD)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
Caffeine (UNII: 3G6A5W338E)
SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GARCINIA KOLA SEED (UNII: 916KUX6Q0N)
Mica (UNII: V8A1AW0880)
Maltodextrin (UNII: 7CVR7L4A2D)
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: 80641-520-01	15 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	01/01/2026

Labeler - Vacation INC. (117644631)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	MANUFACTURE(80641-520)