URBAN DECAY NAKED SKIN ONE AND DONE HYBRID COMPLEXION PERFECTOR BROAD SPECTRUM SPF 20 (OCTINOXATE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]

URBAN DECAY NAKED SKIN ONE AND DONE HYBRID COMPLEXION PERFECTOR BROAD SPECTRUM SPF 20 (OCTINOXATE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-344-01
Set ID b6aa4020-9563-41ec-ac06-9537b6f2c00e
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Octinoxate 7.5%

    Zinc oxide 3.4%

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen 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

    water. isododecane, cyclopentasiloxane, adipic acid/neopentyl glycol crosspolymer, lauryl dimethicone, polyglyceryl-6 polyricinoleate, dimethicone/vinyl dimethicone crosspolymer, isononyl isononanoate, propylene glycol, hydrogenated polyisobutene, polyglyceryl-2 isostearate, glycerin, phenoxyethanol, propanediol, isopropyl myristate, dimethicone crosspolymer, disteardimonium hectorite, sodium chloride, glycyrrhiza glabra (licorice) root extract, xanthan gum, silica, isopropyl titanium triisostearate, stearalkonium hectorate, triethoxycaprylylsilane, aspergillus ferment, evodia rutaecarpa fruit extract,  isoceteth-10, polyhydroxystearic acid, ethoxydiglycol, propylene carbonate, aloe barbadensis leaf juice powder, BHT, sorbic acid; may contain: titanium dioxide, iron oxides

  • Questions or comments?

    Call toll free 1-800-784-URBAN (8722)

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    URBAN DECAY NAKED SKIN ONE AND DONE HYBRID COMPLEXION PERFECTOR BROAD SPECTRUM SPF 20 
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-344
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION34 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
    ISOCETETH-10 (UNII: 1K92T9919H)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SORBIC ACID (UNII: X045WJ989B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-344-011 in 1 CARTON02/01/2016
    140 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 finalpart35202/01/2016
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(49967-344)

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