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Product NDC Code | 62217-003 | ||||||
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Drug Name | Fruit of the earth, inc. luv that sun kids spf 50 natural sunscreen |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LOTION | ||||||
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%, Octocrylene 6.0%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Cetearyl Alcohol, Stearyl Alcohol, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Cetyl Alcohol, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Xanthan Gum, Disodium EDTA, Hydrogenated Methyl Abiete, Lauryl PEG-8 Dimethicone, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate, Copolymer, Sodium Ascorbyl Phosphate, Hibiscus Sabdariffa Flower Extract, Pyrus Malus (Apple) Fruit Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Adansonia Digitata Fruit Extract, Scutellaria Alpina Flower/Leaf/Stem Extract, Trifolium Pratense (Clover) Leaf Extract, Phragmites Communis Extract, Poria Cocos Extract, Polysorbate 20, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Triethanolamine, Propylene Glycol, Hydroxyacetophenone.
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, Inc. Luv That Sun Kids SPF 50 Natural Sunscreen avobenzone, homosalate, octocrylene AVOBENZONE AVOBENZONE GLYCERIN PHENOXYETHANOL COCO GLUCOSIDE HYDROXYACETOPHENONE .ALPHA.-TOCOPHEROL ACETATE ADANSONIA DIGITATA FRUIT WATERMELON WATER STEARYL ALCOHOL METHYL DIHYDROABIETATE LAURYL PEG/PPG-18/18 METHICONE CETETH-10 PHOSPHATE OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE PROPYLENE GLYCOL EDETATE DISODIUM ANHYDROUS PHRAGMITES AUSTRALIS STEM CETOSTEARYL ALCOHOL SCUTELLARIA ALPINA FLOWERING TOP DIHEXADECYL PHOSPHATE CETYL ALCOHOL TROLAMINE CARBOXYPOLYMETHYLENE ALOE VERA LEAF SODIUM ASCORBYL PHOSPHATE XANTHAN GUM POLYSORBATE 20 HIBISCUS SABDARIFFA FLOWER BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER LENS CULINARIS FRUIT FU LING APPLE TRIFOLIUM PRATENSE LEAF
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 Luv that Sun Kids Natural Lotion Sunscreen Broad Spectrum SPF 50 6.0 FL OZ (177 ML) Label
Instructions for use
Information about safe handling and use of the drug product.Directions • apply generously and evenly 15 minutes before sun exposure • reapply as needed or: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months: ask a doctor
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 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 may stain or damage some fabrics, materials or surfaces Sun Protection Measures. Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of aging, skin cancer, and other harmful effects of the sun.
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 if rash or irritation develops and last.
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