Otc - Active Ingredient
Homosalate- 15%
Octocrylene- 6%
Octisalate- 5%
Avobenzone- 2%
Sunplus Spf50 Face Body Sunscreen Lotion
FDA Label NDC 65112-304
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by I.shay Cosmetics for the product Sunplus Spf50 Face Body Sunscreen (NDC 65112-304). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, inactive ingredient, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Otc - Keep Out Of Reach Of Children
WARNING - Keep out of reach of children
Indications & Usage
Helps prevent sunburn and photodamage.
If used as directed with other sun protection measures, decreases the risk of skin cancer and early aging caused by the sun.
Inactive Ingredient
Purified Water, Glycerin, Ceteareth-20, Cetearyl Alcohol, Dimethicone, Glyceryl stearate, PEG-100, Acrylic Polymer, Cetyl Alcohol, Potassium Hexadecyl Phosphate, PEG 300, Grapeseed Oil, Sunflower Oil, Safflower Oil, Organic Borage Oil, Organic Evening Primrose Oil, Allantoin, Hyaluronic Acid, Organic Raspberry Seed Oil, Organic Jojoba Oil, Organic Aloe Oil, Phenoxyethanol, Ethylhexylglycerin
Warnings
For external use only. Do not use on damaged or broken skin. When using this product keep out f eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation occurs. If swallowed get medical help or contact Poison Control Center. Keep out of reach of children.
Dosage & Administration
Apply liberally to dry skin 15 minutes before sun exposure. Reapply to dry skin after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours. Children under 6 months ask a doctor.
* Please review the disclaimer below.
