Soleo Organics Sunscreen Cream
FDA Label NDC 11045-0303

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Se Operations Pty Ltd for the product Soleo Organics Sunscreen (NDC 11045-0303). 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 active ingredients (usa/aus), purpose, uses, warnings, otc - when using, otc - keep out of reach of children, other, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Usa/Aus)

Zinc oxide 22.3% w/w

Purpose

Sunscreen

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

Warnings

  • For external use only

Otc - When Using

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

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children

Other

  • 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

  • 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

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

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)

* Please review the disclaimer below.