Fruit Of The Earth Sun Town City Mineral Spf 70 Lotion Sunscreen

Fruit Of The Earth Sun Town City Mineral Spf 70 Lotion Sunscreen
SPL v2
SPL
SPL Set ID f53fff7a-ef8b-19c4-e053-2a95a90a4a2a
Route
TOPICAL
Published
Effective Date 2021-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Homosalate (150 mg) Avobenzone (30 mg) Octocrylene (100 mg)
Inactive Ingredients
Isodecyl Neopentanoate Diisopropyl Sebacate Lauryl Lactate Cetearyl Olivate Xanthan Gum Ethylhexylglycerin Silicon Dioxide Glyceryl 1-stearate Stearyl/octyldodecyl Citrate Crosspolymer Vinylpyrrolidone/hexadecene Copolymer Water Glycerin Sodium Hydroxide Butyloctyl Salicylate Neopentyl Glycol Diheptanoate Edetic Acid Phenylethyl Alcohol Glyceryl Caprylate Sorbitan Olivate Shea Butter Ethyl Esters Peg-100 Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-11

Description

Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 10.0%

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

Label

Warnings

For external use only

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.m.

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

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

Active Ingredients

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Inactive Ingredients

Water, Shea Butter Ethyl Esters, Isodecyl Neopentanoate, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Cetearyl Olivate, PEG-100 Stearate, Diisopropyl Sebacate, Lauryl Lactate, Sorbitan Olivate, Silica, Glyceryl Caprylate, Stearyl/Octyldodecyl Citrate Crosspolymer, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, VP/Hexadecene Copolymer, Phenethyl Alcohol, Glycerin, Xanthan Gum, Ethylhexylglycerin, Tetrasodium EDTA, Sodium Hydroxide, Fragrance.

When Using This Product

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

Stop Use and Ask A Doctor If

• rash occurs.

Keep Out of Reach of Children

If product is swallowed, get medical help or contact a Poison Control 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

Label

Purpose

Sunscreen

Warnings

For external use only

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.m.

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

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

Active Ingredients (Active ingredients)

Avobenzone 3.0%

Homosalate 15.0%

Octisalate 5.0%

Octocrylene 10.0%

Inactive Ingredients (Inactive ingredients)

Water, Shea Butter Ethyl Esters, Isodecyl Neopentanoate, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Cetearyl Olivate, PEG-100 Stearate, Diisopropyl Sebacate, Lauryl Lactate, Sorbitan Olivate, Silica, Glyceryl Caprylate, Stearyl/Octyldodecyl Citrate Crosspolymer, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, VP/Hexadecene Copolymer, Phenethyl Alcohol, Glycerin, Xanthan Gum, Ethylhexylglycerin, Tetrasodium EDTA, Sodium Hydroxide, 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)

• rash occurs.

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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