Glow Screen Spf 40 Cream
FDA Label NDC 75936-216

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Supergoop, Llc for the product Glow Screen Spf 40 (NDC 75936-216). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients  Purpose
Avobenzone      3% Sunscreen
Octisalate         5% Sunscreen
Octocylene        10% Sunscreen

Otc - Purpose

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Stop use and ask a doctor if rash occurs.

Warnings

Warnings
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.

Dosage & Administration

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 10a.m. – 2p.m.

      •  Wear long-sleeved shirts, pants, hats, and sunglasses
        •  Children under 6 months: Ask a doctor

Inactive Ingredient

Inactive Ingredients
Water, Propanediol, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polymethylsilsesquioxane, Niacinamide, Glyceryl Stearate Citrate, Bismuth Oxychloride, Mica, Titanium Dioxide, Lauryl Lactate, Isododecane, Isodecyl Neopentanoate, Glyceryl Stearate, Diisopropyl Sebacate, Cetyl Phosphate, Caprylic/Capric Triglyceride, Coco-Caprylate, Ethylhexyl Hydroxystearate, Butylene Glycol, Arginine, Hydroxyacetophenone, Caprylyl Glycol, 1,2-Hexanediol, Iron Oxides, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Helianthus Annuus (sunflower) Seed Oil, Ferulic Acid

Package Label.Principal Display Panel

Supergoop!

Glowscreen

SPF 40

Broad Spectrum Sunscreen

SPF 40 PA+++

1.7 fl. oz./ 50 ml.

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