Label: NARUKO TAIWAN MAGNOLIA FIRMING SMOOTH FINISH CREAM MAKEUP- ethylhexyl methoxycinnamate, octocrylene, zinc oxide cream

  • 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 May 8, 2014

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

  • Active ingredients 

    Ethylhexyl Methoxycinnamate (7.65%), Octocrylene(3.08%), Zinc Oxide(3.04%)

  • Purpose

    Sunscreen

  • Keep out of reach of children.

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

  • Uses

    helps prevent sunburn

  • 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.

  • Directions

    apply liberally 15 minutes before sun exposure.

  • Inactive ingredients 

    Diethylamino hydroxybenzoyl hexyl benzoate, Ascorbyl tetraisopalmitate, Phenyl trimethicone, Titanium dioxide,Isononyl isononanoate,Hydrogenated Polyisobutene, Dimethicone, Alumina, Stearic acid, Aluminum starch octenylsuccinate, Polyethylene, Sodium Potassium Aluminum Silicate, Silica, Methyl Methacrylate Crosspolymer, Yellow Iron Oxide, Polyglyceryl-3 Diisostearate, Phenoxyethanol, Ethylhexylglycerin, Dimethicone/Vinyl dimethicone crosspolymer, Magnolia Grandiflora(Michelia Alba) Leaf oil, Red Iron Oxide, Pentaerythrityl Tetraisostearate, Disteardimonium Hectorite, Propylene carbonate, Carnosine, Black Iron oxide, Kalanchoe Spathulata Extract, Glycyrrhiza Glabra (Licorice) root extract, Scutellaria Alpina Flower/Leaf/ Stem Extract, Peucedanam Ostruthium Leaf Extract, Ginkgo Biloba Leaf Extract, Artemisia Umbelliformis Extract, Leontopodium Alpinum Extract, Epilobium Fleischeri Extract, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, BHT, Triethoxycaprylylsilane, Snow Fungus (Tremella Fuciformis extract), Taiwan Magnolia Grandiflora (Michelia Alba) Flower Water, Zingiber Officinale (Ginger) Root Extract, Zizyphus Jujuba Fruit Extract, Eugenia Caryophillus(Clove) flower extract, Prunus Mume Fruit Extract, Cnidium Officinale root Extract, Angelica Acutiloba Root Extract, Hydrolysed Amaranth Protein, Benzyl Alcohol, Ethyl Ascorbic Acid, Vanillomopsis Erythropappa (Flower/Leaf) Oil, Oxalis Triangularis Oil, Camellia Japonica seed oil, Sodium PCA, Trehalose, Sorbitol, Glycerin, Panthenol, Sodium Hyaluronate, Urea,  Polyquaternium-51, Magnolia Officinalis bark Extract, Octyldodecyle Myristate, Coix Lachryma- jobi seed extract, Meadowfoam Seed oil, Lauroyl Lysine,  Hydrolyzed Adansonia Digitata Extract, Brassica Campestris (Rapeseed) sterols, Citearyl alcohol , Bellis Perennis Flower Extract

  • Questions or Comments

    +886-2-2658-1707

  • Packaging

    Naruko carton

  • INGREDIENTS AND APPEARANCE
    NARUKO  TAIWAN MAGNOLIA FIRMING SMOOTH FINISH CREAM MAKEUP
    ethylhexyl methoxycinnamate, octocrylene, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69003-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.65 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.08 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.04 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    POTASSIUM SILICATE (UNII: J86L1GUL6K)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MAGNOLIA GRANDIFLORA LEAF (UNII: J4B095E3UN)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    KALANCHOE PINNATA LEAF (UNII: 3R963LO08T)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SCUTELLARIA ALPINA FLOWERING TOP (UNII: 68JZ9NK55M)  
    PEUCEDANUM OSTRUTHIUM LEAF (UNII: 86P27YRR6Y)  
    GINKGO (UNII: 19FUJ2C58T)  
    ARTEMISIA UMBELLIFORMIS WHOLE (UNII: BI6LY4V6G3)  
    LEONTOPODIUM ALPINUM (UNII: 7R4LQP52DM)  
    EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)  
    MAGNOLIA X ALBA FLOWER OIL (UNII: 8QDN200R1S)  
    GINGER (UNII: C5529G5JPQ)  
    JUJUBE FRUIT (UNII: G55HNL2C70)  
    CLOVE (UNII: K48IKT5321)  
    PRUNUS MUME FRUIT (UNII: 639190I8CU)  
    CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    AMARANTHUS HYPOCHONDRIACUS WHOLE (UNII: YL06Y84R9Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)  
    TAGETES ERECTA WHOLE (UNII: C7YOV7LU4Q)  
    OXALIS CORNICULATA WHOLE (UNII: HJ70WR4413)  
    CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    UREA (UNII: 8W8T17847W)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)  
    OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
    COIX LACRYMA-JOBI SEED (UNII: 4Q4V6NTZ1F)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    ADANSONIA DIGITATA WHOLE (UNII: D5B40OA634)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69003-412-081 in 1 BOX
    18 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/14/2014
    Labeler - Beauty Essentials Limited, Taiwan Branch (656067525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Essentials Limited, Taiwan Branch656067525manufacture(69003-412)