The following Structured Product Label (SPL) was submitted to the FDA by The Soleil Group, Llc for the product Soleil Broad Spectrum Spf-15 (NDC 69630-001). 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 warnings, otc - keep out of reach of children, otc - active ingredient, uses, otc - purpose, directions, other information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Keep out of reach of children
Octinoxate 5.0%, Octisalate
3.0%, Zinc Oxide 2.5%
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.
Sunscreen
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.
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.
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