Vacation Original Coconut Spf 15 Oil
FDA Label NDC 80641-620

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 Original Coconut Spf 15 (NDC 80641-620). 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 (10.0%), Octisalate (5.0%), Octocrylene (10.0%)

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 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 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

Caprylic/Capric Triglyceride, Isopropyl Myristate, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Trimethylpentanediol/Adipic Acid/Glycerin Crosspolymer, Alcohol Denat., Diisopropyl Adipate, Methyl Dihydroabietate, Cocos Nucifera (Coconut) Oil, Passiflora Edulis (Passion Fruit) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Bisabolol, Tocopherol (Vitamin E), Macadamia Integrifolia (Macadamia Nut) Seed Oil, Carica Papaya (Papaya) Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cocos Nucifera (Coconut) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Aleurites Moluccanus (Kukui Nut) Seed Oil, Plumeria Alba (White Frangipani) Flower Extract, Plumeria Rubra (Temple Tree) Flower Extract, Coco-Caprylate, Ethyl Ferulate, Neopentyl Glycol Diheptanoate, Tocopheryl Acetate, Polyester-7, Fragrance

Other Information

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

Principal Display Panel - 147 Ml Bottle Label

VACATION® BRAND

Original

COCONUT
OIL

PREMIUM COCONUT SCENT

WITH
CACAO,
PAPAYA &
VITAMIN E

15

MIAMI,
FLORIDA
U.S.A.
33130

Vacation®

BROAD SPECTRUM SPF 15
SUNSCREEN OIL

5 FL OZ / 147 ML

Principal Display Panel (147 ML Bottle Label)

Principal Display Panel (147 ML Bottle Label)

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