Fruit Of The Earth Cabana Beach Club With Blood Orange And Essential Oils Spf 50 Sunscreen Lotion

Fruit Of The Earth Cabana Beach Club With Blood Orange And Essential Oils Spf 50 Sunscreen Lotion
SPL v2
SPL
SPL Set ID f452f94a-d2f1-60ec-e053-2995a90a8827
Route
TOPICAL
Published
Effective Date 2019-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (45 mg) Octocrylene (80 mg)
Inactive Ingredients
Lime (citrus) Orange Peel Water Glycerin Polyester-7 Neopentyl Glycol Diheptanoate Aluminum Starch Octenylsuccinate Silicon Dioxide Phenoxyethanol Isododecane Arachidyl Alcohol Ethylhexylglycerin Carbomer Copolymer Type A Docosanol .alpha.-tocopherol, Dl- White Wax Arachidyl Glucoside Potassium Hydroxide Glyceryl 1-stearate Peg-100 Stearate Edetate Disodium Sodium Ascorbyl Phosphate Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer

Identifiers & Packaging

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

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Uses

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

Label

Warnings

For external use only

Do Not Use

• on damaged or broken skin.

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

  • 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.,.

• wear long-sleeved shirts, pants, hats, and sunglasses

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Inactive Ingredients

Water, Polyester-7, Neopentyl Glycol Diheptanoate, Glycerin, Aluminum Starch Octenylsuccinate, Styrene/Acrylates Copolymer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantifolia (Lime) Oil, Citrus sinensis (blood orange) oil, Silica, Phenoxyethanol, Isododecane, Arachidyl Alcohol, Beeswax, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Tocopherol (Vitamin E), Arachidyl Glucoside, Glyceryl Stearate, PEG-100 Stearate, Potassium Hydroxide, Disodium EDTA, Sodium Ascorbyl Phosphate, Fragrance.

When Using This Product

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

• 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 protectino measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Label

Purpose

Sunscreen

Warnings

For external use only

Do Not Use (Do not use)

• on damaged or broken skin.

directions (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

  • 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.,.

• wear long-sleeved shirts, pants, hats, and sunglasses

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
Active Ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 4.5%, Octocrylene 8.0%

Inactive Ingredients (Inactive ingredients)

Water, Polyester-7, Neopentyl Glycol Diheptanoate, Glycerin, Aluminum Starch Octenylsuccinate, Styrene/Acrylates Copolymer, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantifolia (Lime) Oil, Citrus sinensis (blood orange) oil, Silica, Phenoxyethanol, Isododecane, Arachidyl Alcohol, Beeswax, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Tocopherol (Vitamin E), Arachidyl Glucoside, Glyceryl Stearate, PEG-100 Stearate, Potassium Hydroxide, Disodium EDTA, Sodium Ascorbyl Phosphate, Fragrance.

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

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

• 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.


Advanced Ingredient Data


Raw Label Data

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