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DRUG FACTS
The following Structured Product Label (SPL) was submitted to the FDA by 9055-7588 Qu�bec Inc.dba Attitude for the product Attitude Sunly Kids Mineral Sunscreen Sprayer Spf 50 Unscented (NDC 61649-532). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
DRUG FACTS
Zinc oxide (24 %)
Sunscreen
Helps prevent sunburn
For external use only.
Do not use on broken skin.
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and consult a doctor if rash occurs
Adultds and children older than 6 months • Spray liberally and spread evenly by hand 15 min before sun exposure. Hold container 4 to 6 inch/10 to 15 cm from the skin to apply. Do not spray directly onto face. Spray on hands then apply to face. Do not apply in windy conditions. Use in a well-ventilated area. Avoid inhaling or exposing others to spray. Reapply at least every 2 h or after 80 min of swimming/sweating or immediately after towel drying. • 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 ≥ 15 and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor.
Ethyl Oleate, Cocoglycerides, Caprylic/Capric Triglyceride, Butylene Glycol Dicaprylate/Dicaprate, Isocetyl Stearoyl Stearate, Calcium Aluminum Borosilicate, Capryloyl Glycerin/Sebacic Acid Copolymer, Hydrogenated Castor Oil/Sebacic Acid Copolymer, Polyhydroxystearic Acid, Cetearyl Olivate, Sorbitan Olivate, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol.
Store at temperatures < 90F and protect from direct sun.
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