Palio Sunscreen Broad Spectrum Spf 30 Cream
FDA Label NDC 87462-909

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sole Palio Llc for the product Palio Sunscreen Broad Spectrum Spf 30 (NDC 87462-909). 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 drug facts, active ingredient, purpose, uses, warnings., do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Avobenzone 3.00 %
Homosalate 8.00 %
Octisalate 5.00 %

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.

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.

Directions.

  • 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 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information.

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Butyloctyl Salicylate, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Paradisi (Grapefruit) Seed Oil, Cocos Nucifera (Coconut) Oil, Diisopropyl Adipate, Dodecane, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil, 1,2-Hexanediol, Lauryl Lactate, Mentha Piperita (Peppermint) Oil, Mica, Ocimum Basilicum (Basil) Extract, Olea Europaea (Olive) Fruit Oil, Oryza Sativa (Rice) Bran Oil, Panthenol, Pentylene Glycol, Phenoxyethanol, Polyester-8, Polyhydroxystearic Acid, Polysorbate 20, Potassium Cetyl Phosphate, Rosmarinus Officinalis (Rosemary) Extract, Silica, Sodium Hydroxide, Sorbitan Olivate, Titanium Dioxide (CI 77891), Tocopherol, Water (Aqua), Xanthan Gum

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