Label: EMINENCE RADIANT PROTECTION SPF FLUID- zinc oxide liquid

  • NDC Code(s): 15751-3506-1
  • Packager: Eminence Organic Skin Care
  • 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 July 10, 2023

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  • Radiant Protection SPF Fluid

    Drug Facts

    Active Ingredient Purpose

    Zinc Oxide 15%……………………...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 doctor if

    rash occurs

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

    Directions

    Shake well before use
    Apply liberally 15 minutes before sun exposure
    Reapply at least every 2 hours
    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.

    Other information

    Protect the product in this container from excessive heat and direct sun.

    Inactive ingredients

    Caprylic/Capric Triglyceride*, Butyloctyl Salicylate, Oryza Sativa (Rice) Wax*, Copernicia Cerifera (Carnauba) Wax*, Triheptanoin, Pentaerythrityl Stearate/Caprate/Caprylate/Adipate, Polyhydroxystearic Acid, Lauroyl Lysine, Methyl Glucose Dioleate, Hydrogenated Poly(C6-20 Olefin),

    HDI/Trimethylol Hexyllactone Crosspolymer, Niacinamide (Vitamin B3), C13-16 Isoalkane, Bakuchiol, Natural Fragrance, Biocomplex2™ [Daucus Carota Sativa (Carrot) Seed Oil*, Euterpe Oleracea (Acai) Fruit Extract*, Citrus Limon (Lemon) Juice*, Malpighia Glabra (Barbados Cherry) Fruit Extract*, Emblica Officinalis (Indian Gooseberry) Fruit Extract*, Adansonia Digitata (Baobab) Fruit Extract*, Myrciaria Dubia (Camu Camu) Fruit Extract*, Daucus Carota Sativa (Carrot) Root Extract*, Cocos Nucifera (Coconut) Water*, Lycium Barbarum (Goji) Fruit Extract*, Helianthus Annuus (Sunflower) Seed Oil*, Plant-Derived Maltodextrin* and Vegetable Glycerin*].

    DISTRIBUTED BY

    Éminence Organic Skin Care

    #300 - 530 West Broadway, Vancouver BC V5Z 1E9

    www.eminenceorganics.com

    1-888-747-6342 (US & Canada Toll Free)

    FORMULATED IN HUNGARY / Made in USA

    Refer to Radiant Protection SPF Fluid US 1.7oz

    Radiant Protection SPF Fluid US 1.7oz Box

  • INGREDIENTS AND APPEARANCE
    EMINENCE RADIANT PROTECTION SPF FLUID 
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15751-3506
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    TRIHEPTANOIN (UNII: 2P6O7CFW5K)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M)  
    ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)  
    MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)  
    DAUCUS CAROTA SUBSP. SATIVUS WHOLE (UNII: F9I9HZH3O3)  
    COCONUT WATER (UNII: 267F5Y81NT)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    BAKUCHIOL (UNII: OT12HJU3AR)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PENTAERYTHRITYL STEARATE (UNII: T9BY3B181Z)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    ACAI (UNII: 46AM2VJ0AW)  
    LEMON (UNII: 24RS0A988O)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    RICE BRAN (UNII: R60QEP13IC)  
    HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15751-3506-11 in 1 BOX09/01/2023
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2023
    Labeler - Eminence Organic Skin Care (205753317)