Label: NATURAL MOISTURIZING FACE SUNSCREEN AND PRIMER- zinc oxide cream

  • NDC Code(s): 69949-010-01, 69949-010-02
  • Packager: Synchronicity Spa, Inc. DBA Suntegrity
  • 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 July 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 20%

  • 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
    • Stop use and ask a doctor if rash occurs
    • When using this product keep out of eyes. Rinse with water to remove.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • childern under 6 months: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including
      • limit time in the sun, especially from 10am-2pm
      • wear long sleeved shirts, pants, hats and sunglasses
  • Inactive Ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Juice1, Capric/Caprylic Triglyceride2, Water (Aqua), Glycerin2, Hydrogenated Castor Oil2, Sorbitan Sesquioleate2, Magnesium Sulfate2, Polyglyceryl-10 Laurate2, Simmondsia Chinensis (Jojoba) Seed Oil1, Helianthus Annuus (Sunflower) Seed Oil1, Cucumis Sativus (Cucumber) Fruit Extract1, Astaxanthin2, Hyaluronic Acid2, Chlorella Emersonii (Red Algae) Extract2, Camellia Sinensis (Green Tea) Extract1, Punica Granatum (Pomegranate) Seed Oil1, Dimethicone, Citrus Sinensis (Sweet Orange) Essential Oil1, Citrus Reticulata Blanco (Tangerine) Essential Oil1, Polyaminopropyl Biguanide, Ethylhexylglycerin

    1
    Certified Organic
    2
    Natural or Naturally-derived ingredients
  • Other Information

    • protect this product from excessive heat and direct sun
  • Questions or Comments?

    Call toll free 1-888-786-5221 M-F, 10:00am-4:00pm PST.

  • SPL UNCLASSIFIED SECTION

    Distributed By:
    Suntegrity® Skincare
    Las Vegas, NV 89128

  • PRINCIPAL DISPLAY PANEL - 50 g Canister Label

    sun
    tegrity®

    NATURAL MOISTURIZING
    FACE SUNSCREEN & PRIMER

    BROAD SPECTRUM SPF30

    "Suntegrity® was made in honor of my Mom
    and all of those who lost their lives to skin cancer.
    May you wear this sunscreen and smile in
    their memory."

    Tricia T.

    NET WT. 1.7 OZ (50 g)

    Principal Display Panel - 50 g Canister Label
  • INGREDIENTS AND APPEARANCE
    NATURAL MOISTURIZING FACE SUNSCREEN AND PRIMER 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69949-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CHLORELLA EMERSONII (UNII: 6701V9L3PV)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    MANDARIN OIL (UNII: NJO720F72R)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69949-010-0150 g in 1 CANISTER; Type 0: Not a Combination Product08/12/2010
    2NDC:69949-010-0250 g in 1 BOX; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/12/2010
    Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)
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