Fruit Of The Earth Cabana Beach Club With Mentha And Essential Oils Spf 50 Continuous Spray

Fruit Of The Earth Cabana Beach Club With Mentha And Essential Oils Spf 50 Continuous Spray
SPL v2
SPL
SPL Set ID c790031d-5448-a998-e053-2a95a90a763e
Route
TOPICAL
Published
Effective Date 2018-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Alcohol Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (75000 Mw) Isododecane Diisopropyl Adipate Peg-12 Dimethicone Caprylyl Glycol .alpha.-tocopherol Acetate Ascorbyl Palmitate Methyl Hydrogenated Rosinate Mineral Oil Panthenol Water Aloe Vera Leaf Spearmint Oil Santalum Spicatum Oil Citrus Sinensis Flower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-30

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

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
Section 51945-4

Warnings

For external use only

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 value 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

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

• on damaged or broken skin.

Other Information
  • protect the product in this container 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, mentha viridis (spearmint) leaf oil, santalum spicatum seed oil (sandalwood), citrus aurantium dulcis (orange) flower oil, ascorbly palmitate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract.

active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

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.

stop Use and Ask A Doctor If

• rash occurs.

keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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
Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

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 value 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

Flammable: (FLAMMABLE:)
  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)
do Not Use (Do not use)

• on damaged or broken skin.

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Inactive Ingredients (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, mentha viridis (spearmint) leaf oil, santalum spicatum seed oil (sandalwood), citrus aurantium dulcis (orange) flower oil, ascorbly palmitate, tocopheryl acetate, mineral oil, panthenol, water, aloe barbadensis leaf extract.

active Ingredients (Active ingredients)

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 5.0%

when Using This Product  (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.

stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• rash occurs.

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.


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