Label: NUORI MINERAL DEFENCE SUNSCREEN SPF 30- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 10, 2022

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 23%

    Purpose: Sunscreen

  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • 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.

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

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

    Stop use and ask a doctor if rash occurs.

  • Directions

    • Apply liberally on clean, moisturized skin 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • For daily use, allow product to absorb completely before applying makeup.
    • Use a water resistant sunscreen if swimming or sweating.
    • 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.

    • Children under 6 months of age: ask a doctor.
  • Inactive ingredients

    Aqua (water), caprylic/capric triglyceride, caprylyl caprylate/caprate, glycerin, silica, arachidyl alcohol, cetearyl alcohol, pongamia glabra (karanja) seed oil, helianthus annuus (sunflower) seed oil, daucus carota sativa (carrot) seed oil, daucus carota sativa (carrot) root extract, pinus pinaster (french maritime pine) bark extract, cetearyl olivate, sorbitan olivate, glyceryl oleate, microcrystalline cellulose, behenyl alcohol, arachidyl glucoside, coco-glucoside, lecithin, polyglyceryl-3 polyricinoleate, hydrogenated palm glycerides citrate, polyhydroxystearic acid, isostearic acid, tocopheryl acetate (vitamin e), ascorbyl palmitate, tocopherol (vitamin e), beta-carotene, glucose, xanthan gum, cellulose gum, citric acid, sodium chloride, hydroxyacetophenone, benzyl alcohol.

  • Other information

    • Protect the product in this container from excessive heat and direct sun
    • You may report a serious adverse reaction to: NUORI Inc., 228 Park Ave S, Ste 300, New York, NY 10003
  • Questions?

    send them to info@nuori.com

  • Company Information

    MANUFACTURED IN ITALY FOR NUORI ApS

    STORMGADE 35/ DK-1555 COPENHAGEN

    NUORI.COM/ @NUORISKINCARE

  • Product Packaging

    NUORI

    SUN

    MINERAL DEFENCE SUNSCREEN

    FACE

    HIGH PROTECTION

    BROAD SPECTRUM SPF 30

    UVA & UVB

    ALL-NATURAL

    PROVEN RESULTS

    50ml 1.7floz

    nuori mineral defence face

  • INGREDIENTS AND APPEARANCE
    NUORI MINERAL DEFENCE SUNSCREEN SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72894-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE230 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    CARROT (UNII: L56Z1JK48B)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72894-003-011 in 1 CARTON06/01/2019
    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 not finalpart35206/01/2019
    Labeler - NUORI ApS (305146468)
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