FDA Label for Suntone Sunscreen Broad Spectrum Spf50
View Indications, Usage & Precautions
Suntone Sunscreen Broad Spectrum Spf50 Product Label
The following document was submitted to the FDA by the labeler of this product Prime Packaging, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 5%
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
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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
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.
Other Safety Information
Flammable:Do not use near heat, flame or while smoking.
Directions
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- hold container 4 to 6 inches from the skin to apply
- do not spray directly into face. Spray on hands then apply to face
- do not apply in windy conditions
- use in a well-ventilated area
- reapply:
- after 80 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 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 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
Inactive Ingredients
Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water
Other Information
• protect this product from excessive heat and direct sun
• avoid spraying on fabrics - could cause discoloration
Questions Or Comments?
Biocycle Laboratories, Inc.
16363 NW 49 Avenue, Miami, FL 33014
Suntone Sport Sunscreen Continuous Spray Broad Spectrum Spf 50
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