Label: SENEGENCE MICROBIOME DEFENSE SUNSCREEN DAYTIME MOISTURIZER SPF15- zinc oxide, octisalate lotion

  • NDC Code(s): 72644-638-01, 72644-638-02
  • Packager: SGII, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 9, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Zinc Oxide (6%)

    Octisalate (5%)

  • Purpose

    Zinc Oxide (6%).............Sunscreen

    Octisalate (5%)..............Sunscreen

  • Uses

    helps prevent sunburn if used as directed with other sun protection measures (see Directions)

  • Warnings

    For external use only. Flammable.

    When using this product keep out of eyes. Rinse with water to remove.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

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

  • Directions

    for sunscreen use:

    • Apply liberally 15 minutes before sun exposure
    • Children under 6 months of age: ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 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
  • Other Information

    • Protect the product in this container from excessive heat and direct sun
  • Inactive Ingredients

    Aqua/Water/Eau, Butylene Glycol, Butyloctyl Salicylate, Isoamyl Laurate, Cetearyl Olivate, Caprylic/Capric Glycerides, Helianthus Annuus (Sunflower) Seed Wax, Lactobacillus Ferment, Vegetable Oil, Sorbitan Olivate, Polyglyceryl-6 Stearate, Coco-Caprylate/Caprate, Glycerin, Saccharomyces Ferment Filtrate, Hydroxyacetophenone, 1,2-Hexanediol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Aronia Melanocarpa Fruit Extract, Polyglyceryl-6 Polyhydroxystearate, Cetyl Alcohol, Polyglyceryl-6 Polyricinoleate, Polyglyceryl-6 Behenate, Simmondsia Chinensis (Jojoba) Seed Oil, Lecithin, Xanthan Gum, Tetrahexyldecyl AScorbate, Tocopherol, Ascorbyl Palmitate, Bisabolol, O-Cymen-5-Ol, Sargassum Glaucescens Extract, Curcuma Longa (Turmeric) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Panthenol, Calanthe Discolor (Ebine) Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Hydrolyzed Opuntia Ficus-Indica (Prickly Pear) Flower Extract, Sodium Hyaluronate, Citric Acid, Gluconolactone, Caprylyl Glycol, Sodium Benzoate, Calcium Gluconate, Laminaria Digitata (Kelp) Extract, Saccharomyces Cerevisiae (Yeast) Extract, Orchis Mascula (Orchid) Flower Extract, Phenoxyethanol, Urea, Glucosamine HCl.

  • PRINCIPAL DISPLAY PANEL

    SeneGence

    Microbiome

    Defense

    Sunscreen Daytime Moisturizer

    Broad Spectrum SPF 15

    SenePlex+

    with Orchid Stem Cells

    1.7 fl oz/50 mL

    1

    2

  • INGREDIENTS AND APPEARANCE
    SENEGENCE MICROBIOME DEFENSE SUNSCREEN DAYTIME MOISTURIZER SPF15 
    zinc oxide, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72644-638
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TURMERIC (UNII: 856YO1Z64F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    ARONIA MELANOCARPA FRUIT (UNII: S935718Z2Q)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CORN OIL (UNII: 8470G57WFM)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WATER (UNII: 059QF0KO0R)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    UREA (UNII: 8W8T17847W)  
    POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-5 CAPRYLIC/CAPRIC GLYCERIDES (UNII: S0SPK283TZ)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    OPUNTIA FICUS-INDICA FLOWER (UNII: 83YSP51SMA)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72644-638-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/10/2024
    2NDC:72644-638-022 mL in 1 PACKET; Type 0: Not a Combination Product05/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/10/2024
    Labeler - SGII, INC (070096792)
    Establishment
    NameAddressID/FEIBusiness Operations
    TCI Co.,Ltd.-BioCosme PABP BRANCH657732201manufacture(72644-638)