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| Product NDC Code | 62217-404 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Fruit of the earth luv that sun sport sunscreen ultra spf 50 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | FRUIT OF THE EARTH, INC. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3.0% Homosalate 15.0% Octisalate 5.0% Octocrylene 7.0%
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, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexyl glycerin, sorbitan isostearate, benzyl alcohol, 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 LUV THAT SUN Sport Sunscreen Ultra SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene WATER TRIDECYL SALICYLATE SORBITOL STEARIC ACID ALUMINUM STARCH OCTENYLSUCCINATE POLYETHYLOXAZOLINE (200000 MW) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) DIMETHICONE .ALPHA.-TOCOPHEROL, DL- EDETATE DISODIUM EDETIC ACID POLYGLYCERYL-3 DISTEARATE CAPRYLYL GLYCOL PHENOXYETHANOL ETHYLHEXYLGLYCERIN SORBITAN ISOSTEARATE BENZYL ALCOHOL TROLAMINE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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 LS58805A
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if • rash occurs.
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 swallowed, get medical help or contact a Poison Control Center right away.
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
Storage and handling
Information about safe storage and handling of the drug product.Other information • protect the product in this container from excessive heat and direct sun • may stain or damage some fabrics/materials or surfaces
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