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| Product NDC Code | 62217-012 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Fruit of the earth sport spf 50 sunscreen continuous |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | AEROSOL, SPRAY | ||||||||||
| Application Number | part352 | ||||||||||
| Labeler Name | Fruit of the Earth, Inc. | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 5.0%
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 • hold can 4-6 inches away from body, spray evenly to ensure complete coverage • do not spray into face. Spray into hand and apply to face. • use in well ventilated, but not windy areas • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 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-sleeve shirts, pants, hats, and sunglasses • children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alcohol denat. (73.2% v/v), acrylates/octylacrylamide copolymer, stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), ascorbic acid (vitamin C), aloe barbadensis leaf juice, fragrance (parfum), caprylic/capric triglyceride
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 • higher SPF gives more sunburn protection
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 Sport SPF 50 Sunscreen Continuous Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone TOCOPHEROL OCTISALATE OCTISALATE ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) ALOE VERA LEAF GLYCERIN STEAROXYTRIMETHYLSILANE DIETHYLHEXYL SYRINGYLIDENEMALONATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES ASCORBIC ACID
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.Fruit of the Earth, Inc. Sport SPF 50 Sunscreen Continuous Spray Representative Image
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information • protect this product from excessive heat and direct sun • may stain or damage some fabrics, materials or surfaces
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 right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comment? Call toll free 1-800-527-7731
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 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. • keep away from face to avoid breathing it in. • do not puncture or incinerate. Contents under pressure. • do not store at temperatures above 120° F.
Storage and handling
Information about safe storage and handling of the drug product.FLAMMABLE: • do not use near heat, flame or while smoking • avoid long term storage above 104°F (40°C)
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