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| Product NDC Code | 75936-608 | ||||||||
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| Drug Name | Glowscreen spf 40 -sunset |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| 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: Avobenzone 3%, Homosalate 4%, Octisalate 5%, Octocrylene 8%
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 generously and evenly 15 minutes before sun exposure • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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 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.Water, Butyloctyl Salicylate, Propanediol, Glycerin, C12-15 Alkyl Benzoate, Iron Oxides, Glyceryl Stearate Citrate, Mica, Isododecane, Niacinamide, Polymethylsilsesquioxane, Glyceryl Stearate, Caprylic/Capric Triglyceride, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Coco-Caprylate, Arginine, Titanium Dioxide, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Bismuth Oxychloride, Sodium Hyaluronate, Chlorphenesin, Ethylhexyl Hydroxystearate, Trisodium Ethylenediamine Disuccinate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Stearoyl Glutamate, Arachidyl Alcohol, Phospholipids, Behenyl Alcohol, Limonium Gerberi Extract, Arachidyl Glucoside, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Triethoxycaprylylsilane, Pantothenic Acid, Tocopherol, Ferulic Acid, Helianthus Annuus (Sunflower) Seed Oil
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
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.Glowscreen SPF 40 -Sunset Avobenzone, Homosalate, Octisalate, Octocrylene ISODECYL NEOPENTANOATE 1,2-HEXANEDIOL BUTYLOCTYL SALICYLATE PROPANEDIOL LAURYL LACTATE GLYCERYL MONOSTEARATE CETYL PHOSPHATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE HYDROXYACETOPHENONE FERULIC ACID ALKYL (C12-15) BENZOATE ISODODECANE MEDIUM-CHAIN TRIGLYCERIDES COCO-CAPRYLATE ARACHIDYL ALCOHOL DOCOSANOL LIMONIUM PLATYPHYLLUM WHOLE ARACHIDYL GLUCOSIDE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE COCOA SUNFLOWER OIL ARGININE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) TITANIUM DIOXIDE BUTYLENE GLYCOL TRIETHOXYCAPRYLYLSILANE PANTOTHENIC ACID TOCOPHEROL CAPRYLYL GLYCOL OMEGA-3 FATTY ACIDS HOMOSALATE HOMOSALATE HYALURONATE SODIUM ETHYLHEXYL HYDROXYSTEARATE CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) SODIUM STEAROYL GLUTAMATE BROWN IRON OXIDE AVOBENZONE AVOBENZONE WATER O-18 GLYCERIN GLYCERYL STEARATE CITRATE DIISOPROPYL SEBACATE MICA NIACINAMIDE TRISODIUM ETHYLENEDIAMINE DISUCCINATE BISMUTH OXYCHLORIDE BISMUTH CATION CHLORPHENESIN
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! Glow Screen SPF 40 Sunset 1.7 fl. oz./ 50 mL Carton
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
Storage and handling
Information about safe storage and handling of the drug product.Protect the product in this container from excessive heat and direct sun
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 • Stop use and ask a doctor if rash occurs • 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