Vacation Grand Cuvee Shimmer Spf 30 Oil
FDA Label NDC 80641-525

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 Grand Cuvee Shimmer Spf 30 (NDC 80641-525). 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.

Label Section Quick Index

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Drug Facts

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

Active Ingredients

Avobenzone (3.0%), Homosalate (5.1%), Octisalate (5.0%), Octocrylene (8.5%)

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. If swallowed, 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-sleeved shirts, pants, hats, and sunglasses
      • Children under 6 months of age: ask a doctor.

Inactive Ingredients

Argania Spinosa (Argan) Kernel Oil, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Oil, C12-15 Alkyl Benzoate, Caesalpinia Sappan Bark Extract, Calcium Sodium Borosilicate, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Dextrin Palmitate, Dimethicone, Ethyl Ferulate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hyaluronic Acid, Iron Oxides, Mica, Musa Paradisiaca (Banana) Fruit Extract, Palmitoyl Tripeptide-1, Prunus Persica (Peach) Kernel Oil, Sclerocarya Birrea (Marula) Kernel Oil, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Tin Oxide, Titanium Dioxide, Tocopherol (Vitamin E), Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Vitis Vinifera (Grape) Seed Oil

Other Information

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

Principal Display Panel - 86 Ml Bottle Label

"GRAND CUVÉE"
SHIMMER OIL
SPF 30

Vacation®

BROAD SPECTRUM
SPF 30 SUNSCREEN OIL

WATER RESISTANT (80 MINUTES)

2.9 FL OZ / 86 ML

Principal Display Panel (86 ML Bottle Label)

Principal Display Panel (86 ML Bottle Label)

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