Fote Cabana Beach Club With Manuka Honey And Essential Oils Spf 30 Sunscreen Aerosol, Spray
FDA Label NDC 62217-041

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fruit Of The Earth, Inc. for the product Fote Cabana Beach Club With Manuka Honey And Essential Oils Spf 30 Sunscreen (NDC 62217-041). 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 active ingredients, purpose, uses, warnings, flammable:, otc - do not use, otc - when using, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 2.0%, Homosalate 7.0%, Octocrylene 5.0%

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 casued by the sun

Warnings

For external use only

Flammable:

  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)

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 • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120°F.

Otc - Ask Doctor

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

  • Spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold can 4-6 inches away from the skin to apply
  • Do not spray directly into face. Spray into hands then apply to face
  • Do not apply in windy conditions
  • Use in a well-ventilated area.
  • Reapply:

    •    • after 80 minutes of swimming or sweating

       • immediately after towel drying

       • at least every 2 hours

    • Children under 6 months of age: ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin 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-sleeve shirts, pants, hats, and sunglasses

Other Information

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive Ingredients

alcohol denat., isododecane, fragrance, diisopropyl adipate, acrylates/octylacrylamide copolymer, VA/butyl maleate/isobornyl acrylate copolymer, PEG-12 dimethicone, caprylyl glycol, hydrogenated methyl abietate, honey (manuka honey), bertholletia excelsa seed oil (brazil nut), vaccinium macrocarpon (cranberry) seed oil, ascorbyl palmitate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract.

Questions Or Comments?

Call toll free 1-800-527-7731

Package Label.Principal Display Panel

FRUIT OF THE EARTH CABANA BEACH CLUB WITH MANUKA HONEY & ESSENTIAL OILS SPF 30 SUNSCREEN CONTINUOUS SPRAY

5.5 OZ (156g)

NDC 62217-041-37

FRUIT OF THE EARTH CABANA BEACH CLUB WITH MANUKA HONEY & ESSENTIAL OILS SPF 30 SUNSCREEN CONTINUOUS SPRAY

2.7 OZ (76.5g)

NDC 62217-041-74

* Please review the disclaimer below.