Label: NURIA DEFEND MATTE FINISH DAILY MOISTURIZER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide and 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 January 31, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Titanium Dioxide 1.65%Sunscreen
    Zinc Oxide 11.0%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

    • For sunscreen use:
      • Apply liberally 15 minutes before sun exposure
      • Use a water resistant sunscreen if swimming or sweating
      • 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, 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 10 a.m. - 2 p.m.
      • Wear long-sleeve shirts, pants, hats, and sunglasses.
    • Children under 6 months: Ask a doctor.
  • Other information

    Protect this product from excessive heat and direct sun

  • Inactive ingredients

    water, caprylic / capric triglyceride, glycerin, sorbitan laurate, isostearyl isostearate, polyglyceryl-4 laurate / succinate, decyl isostearate, citric acid, magnesium aluminum silicate, magnolia biondii bud / flower extract, melissa officinalis leaf extract, prunus persica flower extract, euphrasia officinalis extract, xanthan gum, aluminum stearate, alumina, isostearic acid, lecithin, butylene glycol, polyhydroxystearic acid, sodium benzoate, ethylhexylglycerin, phenoxyethanol

  • Questions?

    Call toll-free (888) 620-6818 or direct (609) 469-3349 from 8 a.m. - 6 p.m. EST Monday - Friday

  • SPL UNCLASSIFIED SECTION

    Distr. by :
    Small World Brands
    Princeton, NJ 08540

  • PRINCIPAL DISPLAY PANEL - 25 mL Bottle Carton

    Nuria™

    Defend
    Matte Finish
    Daily Moisturizer
    Mineral Sunscreen
    Broad Spectrum SPF 30

    with Peach Flower
    native to China

    25 mL / 0.8 fl oz

    PRINCIPAL DISPLAY PANEL - 25 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NURIA DEFEND MATTE FINISH DAILY MOISTURIZER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78611-4146
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide16.5 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide110 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    DECYL ISOSTEARATE (UNII: NRB038QC02)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    MAGNOLIA BIONDII FLOWER BUD (UNII: DZH9BOM6KD)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)  
    EUPHRASIA STRICTA (UNII: C9642I91WL)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78611-4146-11 in 1 CARTON03/15/2021
    125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/15/2021
    Labeler - Small World Brands (104635996)
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