PALIO SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate cream

Palio Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Palio Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Sole Palio LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Labeling:

INGREDIENTS AND APPEARANCE

PALIO SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87462-909
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ALCOHOL (UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
GRAPEFRUIT SEED OIL (UNII: 598D944HOL)
COCONUT OIL (UNII: Q9L0O73W7L)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DODECANE (UNII: 11A386X1QH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL LAURATE (UNII: Y98611C087)
SUNFLOWER OIL (UNII: 3W1JG795YI)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LAURYL LACTATE (UNII: G5SU0BFK7O)
PEPPERMINT OIL (UNII: AV092KU4JH)
MICA (UNII: V8A1AW0880)
BASIL (UNII: 2U0KZP0FDW)
OLIVE OIL (UNII: 6UYK2W1W1E)
RICE BRAN OIL (UNII: LZO6K1506A)
PANTHENOL (UNII: WV9CM0O67Z)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ROSEMARY (UNII: IJ67X351P9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87462-909-00	1 in 1 BOX	02/11/2026
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/11/2026

Labeler - Sole Palio LLC (144945802)

Registrant - Pure Source, LLC (080354456)