Solscents
FDA Label NDC 13630-0076
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Packaging, Inc. for the product Solscents (NDC 13630-0076). 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 principal display panel - 177 ml can label, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, 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
Active Ingredients
Avobenzone 3 %, Homosalate 10%, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 4 %
Purpose
Sunscreen
Uses
- helps prevent sunburn
- If use as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
Otc - When Using
When using this product
- keep away from face to avoid breathing it
- keep out of eyes. Rinse with water to remove.
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.
Directions
- spray liberally and spread evenly by hand 15 minutes before sun exposure. Ensure skin is completely covered with product
- hold container 4-6 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 aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and othe 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
Inactive Ingredients
Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), tocopheryl acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer
Other Information
- avoid spraying on fabrics could cause discoloration
- protect this product from exessive heat and direct sun
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