Label: SOLEO ORGANICS SUNSCREEN- zinc oxide cream

  • NDC Code(s): 11045-0303-1, 11045-0303-2, 11045-0303-3
  • Packager: SE Operations Pty Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 28, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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

    • 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

    • 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
  • INGREDIENTS AND APPEARANCE
    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)
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