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

NAKED SKIN ONE AND DONE DARK (SPF CREAM) CREAM [AUTUMN HARP INC.]
PDF | XML

NDC 51514-0347-1
Set ID 3464086a-030f-4532-e054-00144ff88e88
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 is rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    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, Isononyl Isononanoate, Propylene Glycol, Hydrogenated Polyisobutene, Iron Oxide (CI 77492), Polyglyceryl-2 Isostearate, Glycerin, Phenoxyethanol, Propanediol, Dimethicone Crosspolymer, Disteardimonium Hectorite, Isopropyl Myristate, Sodium Chloride, Glycyrrhiza Glabra (Licorice) Root Extract, Iron Oxides (CI 77491), Aspergillus Ferment, Xanthan Gum, Isoceteth-10, Iron Oxides (CI 77499), Silica, Isopropyl Titanium Triisostearate, Stearalkonium Hectorite, Triethoxycaprylylsilane, Evodia Rutaecarpa Fruit Extract, Ethoxydiglycol, Cyclotetrasiloxane, Propylene Carbonate, Dimethylcyclosiloxane, Polyhydroxystearic Acid, BHT, Sorbic Acid.

  • Questions or comments?

    CALL TOLL FREE

    1-800-784-8722(URBAN)

  • Package Display Panel

    Image Contents Carton LabelTube Label

  • INGREDIENTS AND APPEARANCE
    NAKED SKIN ONE AND DONE DARK 
    spf cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0347
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.4 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ASPERGILLUS FUMIGATUS (UNII: X88DF51T48)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISODODECANE (UNII: A8289P68Y2)  
    LAURYL TRISILOXANE (UNII: 5OHO78HI1D)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
    SORBIC ACID (UNII: X045WJ989B)  
    ISOCETETH-10 (UNII: 1K92T9919H)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0347-140 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp Inc064187883manufacture(51514-0347)

Related Drugs