Vacation Lip Balm Gel
FDA Label NDC 80641-520

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 80641-520). 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

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Drug Facts

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

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.

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 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.

Principal Display Panel - 15 Ml Tube Carton

PEPSI

TINTED LIP GEL
SUNSCREEN

0.5 FL OZ / 15 ML

Principal Display Panel (15 ML Tube Carton)

Principal Display Panel (15 ML Tube Carton)

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