Gopure Sunscreen Lotion
FDA Label NDC 83448-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Natural Lifestyle Brands, Llc Dba Gopure Beauty for the product Gopure Sunscreen (NDC 83448-025). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc oxide 25%
Purpose
Sunscreen
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
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
Other Information
• protect the product in this container from excessive heat and direct sun
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)
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
Packaging
Gopure-025 (83448025 2)
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