Label: SUN GOO MINERAL SUN STICK- zinc oxide stick

  • 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 November 30, 2022

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  • Active Ingredient (s)

    Zinc Oxide 18%

  • Purpose

    Sunscreen

  • 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.

  • 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
    Stop use and ask doctor if rash occurs
    Keep out of reach of children. If a product is swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Apply generously and evenly 15 minutes before sun exposure
    Children under 6 months of age ask a doctor
    Sun protection measures reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every two hours, spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10:00 a.m. – 2:00 p.m. wear long-sleeved shirts, pants, hats and sunglasses.

  • Inactive Ingredients

    Olive oil, beeswax, jojoba seed oil, cocoa seed butter, rosemary leaf extract, shea butter

  • Other information

    Protect the product in this container from excessive heat and direct sun. Do not use if the seal is broken

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    SUN GOO MINERAL SUN STICK 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82395-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ROSEMARY (UNII: IJ67X351P9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82395-001-011 in 1 CARTON11/18/2021
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/18/2021
    Labeler - Sun Goo Inc (118399952)
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