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Gopure sunscreen - Medication Information

Product NDC Code 83448-025
Drug Name

Gopure sunscreen

Type Brand
Active Ingredients
Zinc oxide 25 g/100ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Natural Lifestyle Brands, LLC dba GoPure beauty
Packages
Package NDC Code Description
83448-025-15 1 tube in 1 carton (83448-025-15) / 15 ml in 1 tube
83448-025-50 1 tube in 1 carton (83448-025-50) / 50 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc oxide 25%

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 of age: Ask a doctor • apply to face and neck as the last step in your skincare routine

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, Glycerin, Propanediol, Butyloctyl Salicylate, C13-15 Alkane, Polyhydroxystearic Acid, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, C9-12 Alkane, Isostearic Acid, Isoamyl Laurate, Lecithin, Polyglyceryl-3 Polyricinoleate, Quaternium-90 Bentonite, Coco-Caprylate/Caprate, Caprylhydroxamic Acid, Coconut ( Cocos nucifera ) Fruit Extract, Vanilla ( Vanilla planifolia ) Fruit Extract, Sodium Chloride, Ethyl Vanillin, 1,2- Hexanediol, Galactoarabinan, Triethyl Citrate, Tocopheryl Acetate, Iron Oxides (CI 77492, CI 77491, CI 77499)

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.
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

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
goPure Sunscreen Zinc oxide ZINC OXIDE ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN PROPANEDIOL BUTYLOCTYL SALICYLATE C13-15 ALKANE POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE DODECANE ISOSTEARIC ACID ISOAMYL LAURATE LECITHIN, SUNFLOWER POLYGLYCERYL-3 PENTARICINOLEATE QUATERNIUM-90 BENTONITE COCOYL CAPRYLOCAPRATE CAPRYLHYDROXAMIC ACID COCONUT VANILLA BEAN SODIUM CHLORIDE ETHYL VANILLIN 1,2-HEXANEDIOL GALACTOARABINAN TRIETHYL CITRATE .ALPHA.-TOCOPHEROL ACETATE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE

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.
Packaging goPure-025 image description

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts SAFE & CLEAN Glow Pure Tinted Mineral SPF Broad Spectrum SPF 40 CRUELTY-FREE GLUTEN-FREE DERMATOLOGIST TESTED VEGAN It's glow time @gopurebeauty We created goPure because we believe that everyone deserves to feel confident in their skin - Erin Keyan (goPure co-founder) LET'S GLOW! Manufactured for goPure Beauty 31416 Agoura Rd., Westlake Village, CA 91361 GOOD FACE PROJECT APPROVED ANIMAL TEST-FREE PeTA www.gopurebeauty.com FSC ® C016055 The mark of responsible forestry FPO

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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? +1-800-925-4232 You may also report serious side effects to this phone number. Monday - Friday 9:00 AM - 4:00 PM PST

Storage and handling

Information about safe storage and handling of the drug product.
Other information • 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.
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 Stop use and ask a doctor if • rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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