FDA.reportPublic FDA data

Soleo Organics Sunscreen

Manufacturer
SE Operations Pty Ltd
Effective date
2025-01-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:53:41

Label at a glance#

ProductSoleo Organics Sunscreen
Active ingredientZinc Oxide
Label structure8 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection provides high protection against sunburn retains SPF after 80 minutes of activity in the water

Dosage and administration

Squeeze cream and shake tube well before use apply liberally 20 minutes before sun exposure and as needed store below 30°C/86°F

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (USA/AUS)

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 22.3% w/w

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides high protection against sunburn
  • retains SPF after 80 minutes of activity in the water

Warnings

WARNINGS SECTION

  • For external use only

OTC - WHEN USING SECTION

  • When using this product keep out of eyes, rinse with water to remove

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children

SPL UNCLASSIFIED SECTION

  • Avoid prolonged exposure to the sun
  • Wear protective clothing, hats and eye wear when in the sun
  • Stop use and ask a doctor if rash or irritation develops and lasts

Directions

DOSAGE & ADMINISTRATION SECTION

  • Squeeze cream and shake tube well before use
  • apply liberally 20 minutes before sun exposure and as needed
  • store below 30°C/86°F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, candelilla wax, caprylic/capric triglyceride (plant sourced), coconut extract, cucumber extract, cupuacu butter, grapeseed oil, green tea leaf extract, lecithin, macadamia oil, roman chamomile extract, safflower oil, sunflower oil, vegetable oil, vitamin E (natural)

PRINCIPAL DISPLAY PANEL - 80 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MULTI
AWARD
WINNING
#1
SUNSCREEN

soléo®
organics

ORIGINAL FORMULA
HIGH PERFORMANCE

• SE FORMULA •
SE FORMULA

ALL NATURAL
SUNSCREEN

SPF
30

3hour
very water
resistant*

UV-A
UV-B
Broad Spectrum

80g/2.8 oz e AUST-L 116246

PRINCIPAL DISPLAY PANEL - 80 g Tube Carton
PRINCIPAL DISPLAY PANEL - 80 g Tube Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11045-0303-1Soleo Organics Sunscreen40 g in 1 TUBECREAM406
11045-0303-2Soleo Organics Sunscreen80 g in 1 TUBECREAM806
11045-0303-2Soleo Organics Sunscreen1 in 1 CARTONCREAM16
11045-0303-3Soleo Organics Sunscreen150 g in 1 TUBECREAM1506
11045-0303-3Soleo Organics Sunscreen1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11045-0303SOLEO ORGANICS SUNSCREEN (ZINC OXIDE) CREAM [SE OPERATIONS PTY LTD]6Current NDC, Legacy NDC, 5 package rows20250126_59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Zinc CationACTIVE MOIETY13S1S8SF371

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11045-030311045-0303-1, 11045-0303-2, 11045-0303-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
GRAPE SEED OIL930MLC8XGGIACT
SUNFLOWER OIL3W1JG795YIIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CANDELILLA WAXWL0328HX19IACT
YELLOW WAX2ZA36H0S2VIACT
MACADAMIA OIL515610SU8CIACT
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
SOYBEAN LECITHIN1DI56QDM62IACT
SAFFLOWER OIL65UEH262ISIACT
CUCUMBERYY7C30VXJTIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
Soleo Organics SunscreenZINC OXIDESE Operations Pty Ltd59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b2025-01-22WarningsExact identifier
ndc (package): 11045-0303-2
ndc (package): 11045-0303-3
ndc (package): 11045-0303-1
ndc (product): 11045-0303
ndc11 (package): 11045030303
ndc11 (package): 11045030302
ndc11 (package): 11045030301
spl id: 0dbd6b43-a7ad-46ad-8d5e-44aa8459be89
spl set id: 59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b

Reported adverse events (FAERS/openFDA)#

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