Fruit Of The Earth Sun Town City Mineral Spf 50 Lotion Sunscreen

Fruit Of The Earth Sun Town City Mineral Spf 50 Lotion Sunscreen
SPL v2
SPL
SPL Set ID f45d25d2-9305-5858-e053-2a95a90a7f7b
Route
TOPICAL
Published
Effective Date 2021-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (30 mg) Zinc Cation (150 mg)
Inactive Ingredients
Medium-chain Triglycerides Jojoba Oil Ethylhexylglycerin Phenoxyethanol Silicon Dioxide Aloe Vera Leaf Glyceryl 1-stearate Stearyl/octyldodecyl Citrate Crosspolymer .alpha.-tocopherol, Dl- Oat Magnesium Sulfate Heptahydrate Vinylpyrrolidone/hexadecene Copolymer Olive Oil Polyglyceryl-6 Esters Water Glycerin Sodium Hydroxide Butyloctyl Salicylate Neopentyl Glycol Diheptanoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-27

Description

Titanium Dioxide 3.0% Zinc Oxide 15.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.0% Zinc Oxide 15.0%

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

Titanium Dioxide 3.0%

Zinc Oxide 15.0%

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Glyceryl Stearate, Glycerin, Olive Oil Polyglyceryl-6 Esters, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Phenoxyethanol, Polyglyceryl-6 Pentaoleate, Stearyl/Octyldodecyl Citrate Crosspolymer, VP/Hexadecene Copolymer, Magnesium Sulfate, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Extract, Tocopherol, 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)

Titanium Dioxide 3.0%

Zinc Oxide 15.0%

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/Capric Triglyceride, Neopentyl Glycol Diheptanoate, Butyloctyl Salicylate, Glyceryl Stearate, Glycerin, Olive Oil Polyglyceryl-6 Esters, C30-38 Olefin/Isopropyl Maleate/MA Copolymer, Phenoxyethanol, Polyglyceryl-6 Pentaoleate, Stearyl/Octyldodecyl Citrate Crosspolymer, VP/Hexadecene Copolymer, Magnesium Sulfate, Silica, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Kernel Extract, Tocopherol, 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

All Sections (JSON)