Label: NAKED SKIN ONE AND DONE, MEDIUM- spf cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 14, 2019

If you are a consumer or patient please visit this version.

View All Sections
  • 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

    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)

  • Principle Display Panel

    Tube LabelCarton LabelImage Content

  • INGREDIENTS AND APPEARANCE
    NAKED SKIN ONE AND DONE, MEDIUM 
    spf cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0345
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ASPERGILLUS FUMIGATUS (UNII: X88DF51T48)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ISOCETETH-10 (UNII: 1K92T9919H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIETHYLENE GLYCOL MONOETHYL ETHER ACETATE (UNII: W5EIM81UBX)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SORBIC ACID (UNII: X045WJ989B)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
    LAURYL TRISILOXANE (UNII: 5OHO78HI1D)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0345-040 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 Inc.064187883manufacture(51514-0345)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!