Otc - Active Ingredient
Active Ingredients
Zinc Oxide 18.9%
6000x Elemental Screen Broad Spectrum Spf30 Sunscreen
FDA Label NDC 62742-4200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs Inc for the product 6000x Elemental Screen Broad Spectrum Spf30 Sunscreen (NDC 62742-4200). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
Uses
• helps to 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
Warnings
For external use only
Otc - Do Not Use
Do not use
• on damaged or broken skin
Otc - When Using
When using this product
• keep out of eyes. Rinse with water to remove.
Otc - Ask Doctor
Stop use and ask a doctor if
• rash occurs
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions
• Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor
Reapply:
• after 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 decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10am - 2pm
• wear long-sleeve shirts, pants, hats, and sunglasses
Inactive Ingredient
Inactive Ingredients
Caprylic/Capric Triglyceride, Water(Aqua), Glycerin, Polysorbate 60*, Sorbitan Stearate, Stearic Acid,Cetearyl Glucoside, Cetyl Alcohol, Astaxanthin, Niacinamide (Vitamin B3), Ferulic Acid, Tocopherol (Vitamin E), Totarol (Podocarpus Totara), Mel (Manuka Honey), Phormium Tenax (Harakeke) Seed Oil, Gardenia Jasminoides Meristem Cell Culture, Punica Granatum (Pomegranate)
Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Aloe Barbadensis Leaf Juice, Carrageenan, Lecithin, Xanthan Gum, Sodium Phytate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Dehydroacetic Acid, Stearyl Alcohol, Benzyl Alcohol. *Tween 60-LQ(AP)
Other Safety Information
Other Information
• Protect this product from excessive heat or direct sun
Otc - Questions
Questions or comments?
Email [email protected]
or call (415) 653-3939
Package Label.Principal Display Panel
MANUFACTURED IN THE USA
DISTIL SKINCARE, LLC
BOX 3023, 122 15TH STREET,
DEL MAR, CA 92104, USA
Img6000xdis (Img6000xdis)
* Please review the disclaimer below.
