FDA Label for Soleil Broad Spectrum Spf-50
View Indications, Usage & Precautions
Soleil Broad Spectrum Spf-50 Product Label
The following document was submitted to the FDA by the labeler of this product The Soleil Group, Llc. 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.
Warnings
For external use only. Flammable: Do not use
near heat, flame, or while smoking. 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 the product is
swallowed, get medical help or contact a Poison Control
Center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - Active Ingredient
Octinoxate 5.0%, Octisalate
3.0%, Zinc Oxide 2.5%
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 - Purpose
Sunscreen
Directions
Apply liberally 20 minutes prior to sun
exposure. Do not spray onto face. Spray into hands and apply
to face. Use in well-ventilated areas. Reapply: immediately
after swimming, sweating or towel drying and 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-sleeve shirts, pants, hats and
sunglasses. Children under 6 months: Ask a doctor.
Other Information
May stain or damage some fabrics or
surfaces. Avoid long term storage above 40°C (120°F).
Protect this product from excessive heat and direct sun.
Package Label.Principal Display Panel
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