SOLEO ORGANICS SUNSCREEN - zinc oxide cream 
SE Operations Pty Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Soléo® Organics

Drug Facts

Active Ingredients (USA/AUS)

Zinc oxide 22.3% w/w

Purpose

Sunscreen

Uses

Warnings

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

  • Keep out of reach of children

  • 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

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
SOLEO ORGANICS SUNSCREEN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11045-0303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide223 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GRAPE SEED OIL (UNII: 930MLC8XGG)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MACADAMIA OIL (UNII: 515610SU8C)  
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CUCUMBER (UNII: YY7C30VXJT)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11045-0303-140 g in 1 TUBE; Type 0: Not a Combination Product01/20/2007
2NDC:11045-0303-21 in 1 CARTON01/20/2007
280 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:11045-0303-31 in 1 CARTON01/20/2007
3150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/20/2007
Labeler - SE Operations Pty Ltd (752826854)

Revised: 12/2022
Document Id: b389b6e6-9f4b-467d-9965-36736de8b533
Set id: 59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b
Version: 5
Effective Time: 20221228
 
SE Operations Pty Ltd