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Product NDC Code | 75936-606 | ||||||||
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Drug Name | Glowscreen spf 40 - dawn |
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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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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Avobenzone 3%.......................................Sunscreen Homosalate 4%.......................................Sunscreen Octisalate 5%.......................................Sunscreen Octocrylene 8%.......................................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.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 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 Children under 6 months: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Butyloctyl Salicylate, Propanediol, Titanium Dioxide, Glycerin, C12-15 Alkyl Benzoate, Mica, Glyceryl Stearate Citrate, Isododecane, Niacinamide, Polymethylsilsesquioxane, Glyceryl Stearate, Caprylic/Capric Triglyceride, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Coco-Caprylate, Arginine, Silica, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tin Oxide, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Iron Oxides, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Triethoxycaprylylsilane, Ferulic Acid
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.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 - Dawn Avobenzone, Homosalate, Octisalate, Octocrylene BROWN IRON OXIDE BUTYLENE GLYCOL THEOBROMA CACAO WHOLE LIMONIUM GERBERI FLOWERING TOP AVOBENZONE AVOBENZONE WATER O-18 CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE TITANIUM DIOXIDE GLYCERYL STEARATE CITRATE ISODODECANE GLYCERIN OCTISALATE OCTISALATE COCO-CAPRYLATE PANTOTHENIC ACID TRIETHOXYCAPRYLYLSILANE FERULIC ACID NIACINAMIDE POLYMETHYLSILSESQUIOXANE (11 MICRONS) STANNIC OXIDE TRISODIUM ETHYLENEDIAMINE DISUCCINATE PEG-120 GLYCERYL STEARATE LAURYL LACTATE PROPANEDIOL HOMOSALATE HOMOSALATE BUTYLOCTYL SALICYLATE SILICA, TRIMETHYLSILYL CAPPED 1,2-HEXANEDIOL CAPRYLYL GLYCOL GR-270773 PHOSPHOLIPID EMULSION HELIANTHUS ANNUUS SEED WAX OCTOCRYLENE OCTOCRYLENE CHLORPHENESIN CETYL PHOSPHATE DIISOPROPYL SEBACATE ISODECYL NEOPENTANOATE ALKYL (C12-15) BENZOATE MICA ARGININE TOCOPHEROL ACRYLATES CROSSPOLYMER-6 HYDROXYACETOPHENONE PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
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.SPF 40 Dawn Broad Spectrum Sunscreen SPF 40 PA+++ 1.7 fl. oz. / 50 mL Principal Display Panel
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