Fruit Of The Earth Sun Town City Mineral Spf 30 Lotion Sunscreen

Fruit Of The Earth Sun Town City Mineral Spf 30 Lotion Sunscreen
SPL v2
SPL
SPL Set ID f4481bf3-6dc7-5641-e053-2a95a90ad938
Route
TOPICAL
Published
Effective Date 2022-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (30 mg) Zinc Cation (100 mg)
Inactive Ingredients
Polysorbate 60 Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Anhydrous Citric Acid Docosanol 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 Arachidyl Alcohol Water Glycerin Sorbitan Tristearate Butyloctyl Salicylate Neopentyl Glycol Diheptanoate Soybean Stearyl Alcohol Arachidyl Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-29

Description

Titanium Dioxide 3.0% Zinc Oxide 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.0% Zinc Oxide 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

Titanium Dioxide 3.0%

Zinc Oxide 10.0%

Inactive Ingredients

water, neopentyl glycol diheptanoate, caprylic/capric triglyceride, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, C30-38 olefin/isopropyl maleate/MA copolymer, sorbitan tristearate, silica, stearyl/octldodecyl citrate crosspolymer, VP/hexadecene copolymer, phenoxyethanol, magnesium sulfate, aloe barbadensis leaf juice, glycerine soja (soybean) seed extract, glycerin, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, stearyl alcohol, tocopherol, avena sativa (oat) kernel extract, glyceryl stearate, simmondsia chinensis (jojoba) seed oil, polysorbate 60, ethylhexylglycerin, citric acid, 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 10.0%

Inactive Ingredients (Inactive ingredients)

water, neopentyl glycol diheptanoate, caprylic/capric triglyceride, butyloctyl salicylate, cetyl PEG/PPG-10/1 dimethicone, C30-38 olefin/isopropyl maleate/MA copolymer, sorbitan tristearate, silica, stearyl/octldodecyl citrate crosspolymer, VP/hexadecene copolymer, phenoxyethanol, magnesium sulfate, aloe barbadensis leaf juice, glycerine soja (soybean) seed extract, glycerin, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, stearyl alcohol, tocopherol, avena sativa (oat) kernel extract, glyceryl stearate, simmondsia chinensis (jojoba) seed oil, polysorbate 60, ethylhexylglycerin, citric acid, 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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