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Fruit of the earth sun town city mineral spf 30 sunscreen - Medication Information

Product NDC Code 62217-243
Drug Name

Fruit of the earth sun town city mineral spf 30 sunscreen

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Titanium dioxide 30 mg/ml
Zinc oxide 100 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Fruit Of The Earth, Inc.
Packages
Package NDC Code Description
62217-243-13 100 ml in 1 bottle (62217-243-13)
62217-243-49 42 ml in 1 bottle (62217-243-49)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Titanium Dioxide 3.0% Zinc Oxide 10.0%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE 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 TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION 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

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Label 83675EF 83677F1

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use •on damaged or broken skin.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Poison Control Center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information • protect the product in this container from excessive heat and direct sun • may stain or damage some fabrics, materials or surfaces

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if • rash occurs.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product • keep out of eyes. Rinse with water to remove.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API