Label: BIOSSANCE SQUALANE MOISTURIZER SPF30- zinc oxide lotion

  • NDC Code(s): 73517-381-01, 73517-381-02, 73517-381-03
  • Packager: Amyris, Inc
  • 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 November 3, 2022

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  • Active Ingredients

    Zinc Oxide 14%

    Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

    if used as directed with other sun protection measures(see ​directions)​, decreases the risk of skkin cancer and early signs of aging caused by the sun.

  • Warnings

      For external use only

  • Do not use

    on damaged of broken skin

    When using this product

    keep out of eyes.  Rinse with water to remove

    Stop use and ask

    a doctor if rash occurs

    Keep out of reach of children

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •  Apply generously 15 minutes before sun exposure
    • reapply 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, regularyly 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 shiirts, pants, hats and sunglasses
    • use a water-resistant sunscreen if swimming or sweating
    • children under 6 months of age:ask a doctor.
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Zinc Oxide, Glycerin, Squalane, Cetearyl Alcohol, Methyl Dihydroabietate, Dipropylene Glycol, Sorbitan Olivate, Cetyl Palmitate, Coco Glucoside, Phenoxyethanol, Sodium Palmitoyl Proline, Ethyl Ferulate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylyl/Capryl Glucosides, Butylene Glycol, Nymphaea Alba Flower Extract, Ethylhexylglycerin, Acacia Senegal Gum, Xanthan Gum, Sodium Gluconate, Glucose.

  • PRINCIPAL DISPLAY PANEL

    Figure

  • INGREDIENTS AND APPEARANCE
    BIOSSANCE SQUALANE MOISTURIZER  SPF30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-381
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION14 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALANE (UNII: GW89575KF9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACACIA SENEGAL WHOLE (UNII: QP4QYZ033C)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73517-381-011 in 1 CARTON06/01/2020
    120 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:73517-381-021 in 1 CARTON06/01/2020
    250 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    3NDC:73517-381-031 in 1 CARTON06/01/2020
    3100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02006/01/2020
    Labeler - Amyris, Inc (185930182)
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