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Glow screen body broad spectrum sunscreen spf 40 - Medication Information

Product NDC Code 75936-350
Drug Name

Glow screen body broad spectrum sunscreen spf 40

Type Brand
Active Ingredients
Avobenzone 3 g/100ml
Homosalate 7 g/100ml
Octisalate 5 g/100ml
Octocrylene 10 g/100ml
Route TOPICAL
Dosage Form CREAM
Application Number part352
Labeler Name Supergoop, LLC
Packages
Package NDC Code Description
75936-350-01 100 ml in 1 tube (75936-350-01)
75936-350-02 10 ml in 1 tube (75936-350-02)
75936-350-03 15 ml in 1 tube (75936-350-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Avobenzone 3%..............Sunscreen Homosalate 7%.............Sunscreen Octisalate 5%..................Sunscreen Octocrylene 10%............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 reapply: after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection meausres including: Limit time in the sun, especially from 10 a.m.-2 p.m. Wear long-sleeved shirts, pants, hats, and sunglassess. Children under 6 months: Ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Aletris Farinosa Root Extract, Bisabolol, Butyloctyl Salicylate,Calcium Sodium Borosilicate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryly Glycol, Cetearyl Alcohol, Coco-Caprylate/Caprate, Coco-Glucoside, Coconut Alkanes, Erythritol, Ethyl Ferulate, Ethylhexyl Methoxycrylene, Glycerin, Glyceryl Stearate, Hydrogenated Polycyclopentadiene, Methyl Dlhydroabietate, Mica, Polyester-8, Propanedlol, Sodium Gluconate, Sodium Polyacrylate Starch, Sodium Stearoyl Glutamate, Titanium Dioxide, Tocopherol, Water, Xanthan Gum

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.
Glow Screen Body Broad Spectrum Sunscreen SPF 40 Avobenzone, Homosalate, Octisalate, Octocrylene CAPRYLHYDROXAMIC ACID MEDIUM-CHAIN TRIGLYCERIDES PROPANEDIOL WATER ERYTHRITOL ETHYL FERULATE CETOSTEARYL ALCOHOL ALETRIS FARINOSA ROOT LEVOMENOL BUTYLOCTYL SALICYLATE TITANIUM DIOXIDE COCO GLUCOSIDE COCONUT ALKANES ETHYLHEXYL METHOXYCRYLENE GLYCERIN CAPRYLYL GLYCOL COCO-CAPRYLATE/CAPRATE GLYCERYL MONOSTEARATE MICA SODIUM GLUCONATE SODIUM STEAROYL GLUTAMATE TOCOPHEROL POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) XANTHAN GUM METHYL DIHYDROABIETATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE

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 Body SPF 40 Broad Spectrum Sunscreen SPF 40 PA+++ Water & Sweat Resistant (40 minutes) 3.4 fl. oz. / 100 ml. Tube 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 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.
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. 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