Label: SQUALANE PLUS MINERAL SPF 45- titanium dioxide and 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 February 25, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium Dioxide 4.069%
    Zinc Oxide 7%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early signs of 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 and evenly to face and neck 15 minutes before sun exposure. Reapply:
      • After 80 minutes of swimming or sweating. Immediately after towel drying.
      • At least every 2 hours.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum value of SPF 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 a.m. – 2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months of age: Ask a doctor.
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Squalane, Polyglyceryl-3 Sorbityl Linseedate, Cetyl Dimethicone, Dimethicone, Polymethylsilsesquioxane, Glycerin, Styrene/Acrylates Copolymer, Thermus Thermophilus Ferment, Polyhydroxystearic Acid, Synthetic Fluorphlogopite, Sodium Chloride, Hydroxyacetophenone, Tocopheryl Acetate, Saccharide Isomerate, Caramel, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Disteardimonium Hectorite, Triethoxycaprylylsilane, Bisabolol, Benzylidene Dimethoxydimethylindanone, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Zingiber Officinale (Ginger) Root Extract

  • Other Information

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics.
  • Questions or Comments?

    Call toll free 1-844-688-5885

  • PRINCIPAL DISPLAY PANEL - 50 ML Tube Carton

    BIOSSANCE

    SQUALANE +
    MINERAL SPF 45

    BROAD SPECTRUM
    UVA/UVB FACIAL
    SUNSCREEN LOTION

    45

    Protects, Primes
    & Hydrates Face

    50ML/1.6907 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 50 ML Tube Carton
  • INGREDIENTS AND APPEARANCE
    SQUALANE PLUS MINERAL SPF 45 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40.69 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Squalane (UNII: GW89575KF9)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Glycerin (UNII: PDC6A3C0OX)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    Thermus Thermophilus Lysate (UNII: 775R692494)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Hydroxyacetophenone (UNII: G1L3HT4CMH)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Saccharide Isomerate (UNII: W8K377W98I)  
    Caramel (UNII: T9D99G2B1R)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Levomenol (UNII: 24WE03BX2T)  
    Benzylidene Dimethoxydimethylindanone (UNII: 75HIF3C97L)  
    Citrus Aurantium Flower (UNII: O730ZX2Z83)  
    Ginger (UNII: C5529G5JPQ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73517-123-011 in 1 CARTON03/01/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/01/2018
    Labeler - Amyris, Inc. (185930182)
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