Active Ingredients
Homosalate 10.0% w/w
Zinc Oxide 5.7% w/w
Octocrylene 5.0% w/w
Sunsorb Reef Safe Spf50 Lotion
FDA Label NDC 65008-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Qs Key West Aloe, Llc for the product Sunsorb Reef Safe Spf50 (NDC 65008-007). 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 active ingredients, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Do not use on damaged or broken skin
When using this product
- Keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if
- Rash or irritation develops and lasts
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
- Apply liberally 15 minutes before sun exposure
- Reapply
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hrs
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other skin protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
Otc - Ask Doctor/Pharmacist
- Children under 6 months: Ask a doctor
Inactive Ingredients:
Water, Aloe Barbadensis Leaf Extract, Hydrogenated Polybutene, Polyglyceryl-4-Isostearate, Cyclomethicone, Octyl Stearate, Isopropyl Palmitate, Sunflower Oil, Emulsifying Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3 Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Caprylyl Glycol, Methylisothiazolinone.
Other Information
- Protect this product from excessive heat and direct sun.
Questions Or Comments?
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