NAKED ONE AND DONE CREAM LIGHT (SPF CREAM) CREAM [AUTUMN HARP INC.]

NAKED ONE AND DONE CREAM LIGHT (SPF CREAM) CREAM [AUTUMN HARP INC.]
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NDC 51514-0343-1
Set ID 31f614e2-9298-0c47-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • DRUG FACTS:

  • 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 exposer. 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, Aloe Barbadensis Leaf Juice, Titanium Dioxide, Polyglyceryl-6 Polyricinoleate, Dimethicone/Vinyl Dimethicone Crosspolymer, Propylene Glycol, Isononyl Isononanoate, Hydrogenated Polyisobutene, Polyglyceryl-2 Isostearate, Glycerin, Phenoxyethanol, Propanediol, Dimethicone Crosspolymer, Disteardimonium Hectorite, Isopropyl Myristate, Iron Oxide (CI 77492), Sodium Chloride, Glycyrrhiza Glabra (Licorice) Root Extract, Aspergillus Ferment, Xanthan Gum, Isoceteth-10, Silica, Iron Oxides (CI 77491), Isopropyl Titanium Triisostearate, Triethoxycaprylylsilane, Stearalkonium Hectorite, Evodia Rutaecarpa Fruit Extract, Ethoxydiglycol, Cyclotetrasiloxane, Dimethylcyclosiloxane, Iron Oxides (CI 77499), Propylene Carbonate, Polyhydroxystearic Acid, BHT, Sorbic Acid, may contain: titanium dioxide, iron oxides

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    image content Carton artworkTube Artwork

  • INGREDIENTS AND APPEARANCE
    NAKED ONE AND DONE CREAM LIGHT 
    spf cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0343
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.49 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.43 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ASPERGILLUS FUMIGATUS (UNII: X88DF51T48)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOCETETH-10 (UNII: 1K92T9919H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SORBIC ACID (UNII: X045WJ989B)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    ISODODECANE (UNII: A8289P68Y2)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    WATER (UNII: 059QF0KO0R)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0343-11 g in 1 TUBE; Type 0: Not a Combination Product02/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/04/2016
    Labeler - Autumn Harp Inc. (064187883)
    Registrant - Autumn Harp Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp Inc.064187883manufacture(51514-0343)

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