Otc - Active Ingredient
Octocrylene 3%
Homosalate2%
Octisalate 2%
Avobenzone 2%
Sunplus Lip Life Stick
FDA Label NDC 65112-303
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 Lip Life (NDC 65112-303). 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 protection
Otc - Keep Out Of Reach Of Children
WARNING: Keep out of reach of children.
Indications & Usage
Helps prevent sunburn
Higher SFP gives more sunburn protection
Retains SPF after 40 minutes of swimming or sweating
If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the Sun.
Inactive Ingredient
Coconut oil, Caprylic, BehenylBehenate, Sunflower oil, Carnauba Wax, Candelilla Wax, Flavor, Glycerin, Safflower oil, Stevia, PolyhydroxystearicAcid, Organic Raspberry oil, Organic Jojoba oil, Organic Evening primrose oil, Organic Aloe vera oil, Lanolin acid, Tocopherol Acetate.
Warnings
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 or irritation develops and lasts.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breastfeeding, ask a health professional before use.
Dosage & Administration
Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. 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 cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including limit time in the sun, especially from 10am - 2pm, wear long-sleeved shirts, pants, hats, and sunglasses.
* Please review the disclaimer below.
