Label: NATURAL SUNSCREEN- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 5, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient                                  Purpose

    Zinc Oxide ............................................... 24.96%

  • PURPOSE

    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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Natural Sunscreen

    MooGoo

    "Zinc only thanks"

    SPF 30

    Rubs in Clear

    Water Based (Less Greasy)

    UVA + UVB Broad Spectrum

    For Children & Adults

    WATER RESISTANT 40MIN

    Active Ingredient 

    Zinc Oxide 24.96% w/w

  • DOSAGE & ADMINISTRATION

    Directions

    Apply liberally 15 minutes before sun exposure

    Reapply:

    • after 40 minutes of swimming or sweating
    • immediately after towel drying
    • if rubbed off by clothing or water

    Sun Protection Measures: This Zinc based sunscreen reflects and scatters more than 97% of UV rays. In addition to sunscreen, limit time in peak sun and wear a hat. All natural products should be patch tested before use.

  • WARNINGS

    Warnings

    • For external use only
    • Do not use on damaged or broken skin
    • When using this product keep out of eyes. Rinse with water to remove.
    • All natural products should be patch tested before use. Stop use if rash occurs.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, jojoba oil, galactoarabinan, beeswax, coco caprylate, sorbitan olivate & lecithin & polyglyceryl-2 dipolyhydroxystearate & cetyl phosphate & polyglyceryl-3 polyricinoleate, & oleic acid, glycerin, tropolone, capryl glycol, sodium chloride (salt).

  • LABEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    NATURAL SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69788-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION24.96 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69788-000-01120 g in 1 PACKAGE; Type 0: Not a Combination Product04/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/07/2015
    Labeler - MooGoo USA LLC (076343899)
    Establishment
    NameAddressID/FEIBusiness Operations
    MooGoo USA LLC076343899manufacture(69788-000)
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