URBAN DECAY NAKED SKIN DARK BEAUTY BALM SPF20 (OCTINOXATE, ZINC OXIDE) LOTION [AUTUMN HARP, INC.]

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  • URBAN DECAY NAKED SKIN DARK BEAUTY BALM SPF20 (OCTINOXATE, ZINC OXIDE) LOTION [AUTUMN HARP, INC.]

URBAN DECAY NAKED SKIN DARK BEAUTY BALM SPF20 (OCTINOXATE, ZINC OXIDE) LOTION [AUTUMN HARP, INC.]
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NDC 51514-0333-1, 51514-0333-2
Set ID ce9746a4-2b95-495d-af27-02a94d6b0af3
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • WARNINGS AND PRECAUTIONS

    Drug Facts

  • Active Ingredient

    Octinoxate (7.5%)

    Zinc Oxide (3.4%)

  • Purpose

    Sunscreen

    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.

  • BOXED WARNING (What is this?)

    Warnings

    For external use only

  • SAFE HANDLING WARNING

    Do not use on damaged or broken skin.

  • WARNINGS AND PRECAUTIONS

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

  • WARNINGS

    Stop use and ask a doctor if rash occurs.

  • USER SAFETY WARNINGS

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

  • Directions

    • 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 the 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 10am - 2pm.

    • Wear long-sleeve shirts, pants, hats, and sunglasses

    • Children under 6 months: Ask a doctor

  • Inactive Ingredients

    Cyclopentasiloxane, Water, Isododecane, Adipic Acid / Neopentyl Glycol Crosspolymer, Lauryl Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Lauryl PEG/PPG-18/18 Methicone, Glycerin, Hydrogenated Polyisobutene, Propanediol, Phenoxyethanol, Dimethicone Crosspolymer, Disteardimonium Hectorite, Isononyl Isononanoate, Sodium Chloride, PEG/PPG-18/18 Dimethicone, Isopropyl Myristate, Xanthan Gum, Propylene Carbonate, Isoceteth-10, Silica, Lysine HCL, Fragrance, Lecithin, Citrullus Lanatus (Watermelon) Fruit Extract, Triethoxycaprylylsilane, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Citrulline, Polyhydroxystearic Acid, Biacalin, Linalool, Limonene, Tripeptide-9 Citrulline, Geraniol, Citral, Eugenol, Coumarin, Citronellol. May contain: Cl 77891 (Titanium Dioxide), Cl 77491/77499 (Iron Oxicdes).

  • Other Information

    Protect this product from excessive heat and direct sun light.

  • Questions or comments

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

  • Principal Display Panel

    Image Components15 ml unit carton artwork35 ml unit carton artworkshade label for both 15 ml & 35 ml

  • INGREDIENTS AND APPEARANCE
    URBAN DECAY NAKED SKIN DARK BEAUTY BALM SPF20 
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION3.4 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    Isododecane (UNII: A8289P68Y2)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    NEOPENTYL GLYCOL (UNII: QI80HXD6S5)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propanediol (UNII: 5965N8W85T)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Disteardimonium Hectorite (UNII: X687XDK09L)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Propylene Carbonate (UNII: 8D08K3S51E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Isoceteth-10 (UNII: 1K92T9919H)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    ROSEMARY (UNII: IJ67X351P9)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    watermelon (UNII: 231473QB6R)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)  
    Stearalkonium Hectorite (UNII: OLX698AH5P)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CITRULLINE (UNII: 29VT07BGDA)  
    Baicalin (UNII: 347Q89U4M5)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    GERANIOL (UNII: L837108USY)  
    CITRAL (UNII: T7EU0O9VPP)  
    EUGENOL (UNII: 3T8H1794QW)  
    COUMARIN (UNII: A4VZ22K1WT)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0333-135 mL in 1 TUBE
    2NDC:51514-0333-215 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/05/2013
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0333)
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