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

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

URBAN DECAY NAKED SKIN ILLUMINATING BEAUTY BALM SPF20 (OCTINOXATE, ZINC OXIDE) LOTION [AUTUMN HARP, INC.]
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NDC 51514-0335-1
Set ID 74f4db1f-171d-43e0-8a49-1024edbb3376
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, Mica, Hydrogenated Polyisobutene, Glycerin, Propanediol, Phenoxyethanol, Dimethicone Crosspolymer, Disteardimonium Hectorite, Isononyl Isononanoate, Sodium Chloride, PEG/PPG-18/18 Dimethicone, Xanthan Gum, Isopropyl Myristate, Propylene Carbonate, Isoceteth-10, Isostearyl Alcohol, Propylene Oxide Polymer, Silica, Lysine HCL, Fragrance, Lecithin, Citrullus Lanatus (Watermelon) Fruit Extract, Triethoxycaprylylsilane, Methylalkyl Cyclosiloxanes, Cyclotetrasiloxane, Isopropyl Titanium Triisostearate, Dimethylcyclosiloxane, Stearalkonium Hectorite, Baicalin, Polyhydroxystearic Acid, Citrulline, BHT, Linalool, Limonene, Potassium Sorbate, Sodium Benzoate, Tripeptide-9 Citrulline, Geraniol. May contain: CI77891 (Titanium dioxide), CI77491/77492/77499 (Iron Oxides), CI75470 (Carmine).

  • 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

    ComponentCarton Image Components

  • INGREDIENTS AND APPEARANCE
    URBAN DECAY NAKED SKIN ILLUMINATING BEAUTY BALM SPF20 
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0335
    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 OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.4 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)  
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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)  
    ISOCETETH-10 (UNII: 1K92T9919H)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    DODECENE (UNII: WYE669F3GR)  
    PROPYLENE OXIDE (UNII: Y4Y7NYD4BK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    ROSEMARY (UNII: IJ67X351P9)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATERMELON (UNII: 231473QB6R)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CARMINIC ACID (UNII: CID8Z8N95N)  
    BAICALIN (UNII: 347Q89U4M5)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CITRULLINE (UNII: 29VT07BGDA)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ACV TRIPEPTIDE (UNII: O3VOU3H9VS)  
    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:51514-0335-135 mL in 1 TUBE; Type 0: Not a Combination Product
    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(51514-0335)
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