Vacation Mineral Broad Spectrum Spf 30 Sunscreen
FDA Label NDC 80641-002

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 Mineral Broad Spectrum Spf 30 Sunscreen (NDC 80641-002). 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 - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

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

Active Ingredients

Zinc Oxide 20%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product, keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months of age: ask a physician.

Inactive Ingredients

Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Extract, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Caprylate/Caprate, Caprylyl Glyceryl Ether, Cucumis Sativus (Cucumber) Fruit Extract, Dicaprylyl Carbonate, Diheptyl Succinate, Galactoarabinan, Glycerin, Helianthus Annuus (Sunflower) Extract, Magnesium Sulfate, Methyl Dihydroabietate, Niacinamide (Vitamin B3), Oryza Sativa (Rice) Bran Extract, Polyglyceryl-2 Oleate, Polyglyceryl-2 Stearate, Polyhydroxystearic Acid, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (Vitamin E), Triethoxycaprylylsilane, Water

Other Information

  • Protect this product from excessive heat and direct sun

Principal Display Panel - 100 Ml Tube Label

Vacation®

Mineral Lotion
BROAD SPECTRUM SPF 30 SUNSCREEN

By the "Legendary" Vacation® of Miami—
"Luxury-Grade" Non-Nano Zinc Formula
Sunscreen for "Long Days by the Pool"
Water-Resistant (80 Minutes)
"Leisure-Enhancing"

SPF 30

3.4 FL OZ / 100 ML

Principal Display Panel (100 ML Tube Label)

Principal Display Panel (100 ML Tube Label)

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