FDA.reportPublic FDA data

Palio Sunscreen Broad Spectrum SPF 30

Manufacturer
Sole Palio LLC | Pure Source, LLC
Effective date
2026-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:48:59

Label at a glance#

ProductPalio Sunscreen Broad Spectrum SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE
Label structure7 sections

Indications and 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.

Dosage and 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 ...

Label contents#

Full prescribing information#

Active Ingredient 

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00 %
Homosalate 8.00 %
Octisalate 5.00 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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.

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • On damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions.

DOSAGE & ADMINISTRATION SECTION

  • 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.

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87462-909-00Palio Sunscreen Broad Spectrum SPF 301 in 1 BOXCREAM11
87462-909-00Palio Sunscreen Broad Spectrum SPF 3050 mL in 1 TUBECREAM501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87462-90987462-909-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAF JUICERUE8E6T4NBIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
DOCOSANOL9G1OE216XYIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETEARYL OLIVATE58B69Q84JOIACT
ALCOHOL3K9958V90MIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATERMELON231473QB6RIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
GRAPEFRUIT SEED OIL598D944HOLIACT
COCONUT OILQ9L0O73W7LIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
DODECANE11A386X1QHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
SUNFLOWER OIL3W1JG795YIIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
LAURYL LACTATEG5SU0BFK7OIACT
PEPPERMINT OILAV092KU4JHIACT
MICAV8A1AW0880IACT
BASIL2U0KZP0FDWIACT
OLIVE OIL6UYK2W1W1EIACT
RICE BRAN OILLZO6K1506AIACT
PANTHENOLWV9CM0O67ZIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ROSEMARYIJ67X351P9IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN OLIVATEMDL271E3GRIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Palio Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATESole Palio LLC071d5113-8fe8-44bb-8322-542eafc2800a2026-03-05WarningsExact identifier
ndc (package): 87462-909-00
ndc (product): 87462-909
ndc11 (package): 87462090900
spl id: 4c45a698-61ff-9bfd-e063-6294a90ae176
spl set id: 071d5113-8fe8-44bb-8322-542eafc2800a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.