Label: PREBIOTIX SPF 45 GLOW- zinc oxide lotion

  • 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 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide 22%

  • 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 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

    • Due to the nature of mineral formulations shake and knead the tube before use. Moisturize daily by applying generously and evenly 15 minutes before sun exposure. May be used over moisturizer or alone.
    • 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 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
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months: Ask a doctor.
  • Inactive Ingredients

    Aloe barbadensis leaf juice1, butyloctyl salicylate, caprylic/capric triglyceride2, polyester-8, glycerin1, cetearyl alcohol2, glyceryl stearate2, glycolipids2, squalane2, sorbitan sesquioleate2, isoamyl laurate2, vitis vinifera (grape) seed oil1, simmondsia chinensis (jojoba) seed oil1, hyaluronic acid, coco-glucoside2, hydrolyzed jojoba esters2, tocopherol (Vitamin E)2, bisabolol2, ectoin2, hydrolyzed viola tricolor extract2, phyllanthus emblica fruit extract2, inulin2, glyceryl caprylate2, mica, iron oxides, caprylhydroxamic acid2, polyhydroxystearic acid, lysolecithin2, sclerotium gum2, xanthan gum2, pullulan2, sodium stearoyl glutamate, sodium riboflavin phosphate, leuconostoc/radish root ferment filtrate2, maltodextrin2, titanium dioxide, silica, citric acid.

    1
    certified organic ingredient
    2
    plant-derived
  • Other Information

    • Protect the product in this container from excessive heat and direct sun
  • Questions?

    Email customerservice@juicebeauty.com or visit www.juicebeauty.com

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    JUICE BEAUTY
    PREBIOTIX®
    SPF 45 Glow

    Daily Multi-Tasking
    Moisturizer

    broad spectrum
    SPF 45 sunscreen

    50 mL / 1.7 fl oz
    NPN 80122647

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    PREBIOTIX SPF 45 GLOW 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55165-0301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide22 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PSEUDOMONAS GLUCOSE FERMENTATION RHAMNOLIPIDS (UNII: PB22NX2CJL)  
    SQUALANE (UNII: GW89575KF9)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ECTOINE (UNII: 7GXZ3858RY)  
    VIOLA TRICOLOR WHOLE (UNII: 9Q24RAI43V)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    INULIN (UNII: JOS53KRJ01)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    RIBOFLAVIN 5'-PHOSPHATE SODIUM ANHYDROUS (UNII: 957E53WV42)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55165-0301-150 mL in 1 TUBE; Type 0: Not a Combination Product02/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/19/2023
    Labeler - Juice Beauty (263151582)
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