Vacation Lip Balm Gel
FDA Label NDC 80641-720

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vacation Inc. for the product Vacation Lip Balm (NDC 80641-720). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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.

Otc - Stop Use

  • Stop use if rash occurs.

Otc - Keep Out Of Reach Of Children

  • 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.

Principal Display Panel - 15 Ml Tube Carton

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)

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