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| Product NDC Code | 75936-227 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Play body mousse with blue sea kale broad spectrum spf 50 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Supergoop, LLC | ||||||
| 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 Purpose Avobenzone3% Sunscreen Homosalate 15% Sunscreen Octisalate 5% Sunscreen
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.Apply generously and evenly 15 minutes before sun exposure Use a water-resistant sunscreen if swimming or sweating Reapply 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 value of 15 or higher and other sun protection measures including: • limit your time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aluminum Starch Octenylsuccinate, Ananas Sativus (Pineapple) Fruit Extract, Bis-Hydroxyethoxypropyl Dimethicone,Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Cananga Odorata Flower Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cocos Nucifera (Coconut) Fruit Extract, Cocos Nucifera (Coconut) Oil, Coffea Arabica (Coffee) Seed Extract, Crambe Maritima Leaf Extract, Cucumis Melo Cantalupensis Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Olea Europaea (Olive) Fruit Oil, Panthenol, Passiflora Incarnata Fruit Extract, Persea Gratissima (Avocado) Oil, Polyester-5, Potassium Cetyl Phosphate, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Rubus Idaeus (Raspberry) Fruit Extract, Santalum Album (Sandalwood) Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Trehalose, Vanilla Planifolia Fruit Extract, Water
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.Stop use and ask a doctor if rash occurs or irritation develops and lasts.
Purpose
Information about the drug product’s indications for 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.
Spl product data elements
Usually a list of ingredients in a drug product.Play Body Mousse with Blue Sea Kale Broad Spectrum SPF 50 Avobenzone, Homosalate, Octisalate AVOCADO OIL APPLE COCONUT ARABICA COFFEE BEAN EDETATE DISODIUM GLYCERYL MONOCAPRYLATE GLYCERYL 1-UNDECYLENATE VANILLA BEAN CANTALOUPE CUCUMBER OLIVE OIL ALMOND RASPBERRY TREHALOSE TOCOPHEROL WATER POLYESTER-5 (TG-48) POTASSIUM CETYL PHOSPHATE SANDALWOOD COCOA PUMMELO SHEA BUTTER LEMON PEEL CAPRYLYL GLYCOL ALKYL (C12-15) BENZOATE BUTYLOCTYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES CHLORPHENESIN ORANGE PEEL GLYCERIN ALUMINUM STARCH OCTENYLSUCCINATE CANANGA ODORATA FLOWER PANTHENOL PASSIFLORA INCARNATA FRUIT APRICOT JOJOBA OIL CETOSTEARYL ALCOHOL COCONUT OIL CRAMBE MARITIMA LEAF DIETHYLHEXYL SYRINGYLIDENEMALONATE GLYCERYL MONOSTEARATE ALMOND OIL PINEAPPLE BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE
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.Supergoop! PLAY SPF 50 Body Mousse With Blue Sea Kale Broad Spectrum Suncreen SPF 50 Water and Sweat Resistant (80 minutes) 84 ml e 86 g 3.0 oz Body Mousse 50
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
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.For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove
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