Label: PRIVATE LABEL MOISTURIZING OIL FREE PARABEN FREE SPF43- sunscreen lotion

  • NDC Code(s): 60232-0007-1
  • Packager: Swiss-American CDMO, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 31, 2017

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

  • Warnings

    For external use only.  Do not use on damaged or broken skin.  Stope use and ask doctor if rash occurs. When using the product keep out of eyes; rinse with water to remove.  Keep out of reach of children.  If swallowed, get medical help or contact poison control immediately.  Protect this product from excessive heat and direct sun.

  • Uses

    Helps prevent sunbrun an dphoto damage caused by UVA/UVB exposure.  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.

  • Active Ingredients

    Zinc Oxide   7.50%

    Octinoxate   7.50%

    Octisalate   2.50%

  • Keep out of reach of children

    Keep out of reach of children.

  • Directions

    Apply liberally 15 minutes before exposure to the sun.  Use a water resistant sunscreen if swimming or sweating.  Reapply at least every 2 hours.  Children under 6 months of age, ask physician.  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. to 2 p.m.  Wear long-sleeved shirts, pants, hats and sunglasses.

  • Other Ingredients

    Water, Isopropyl Palmitate, Octyl Stearate, Ethylhexyl Isononanoate, Cylcopentasiloxane, Cetearyl Glucoside, Dimethicone, Glycerth-26, Sodium Hyaluronate, Panthenol, Allantoin, Tocopheryl Acetate, Ascorbyl Palmitate, Oleth-3 Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyisobutene, PEG-7 Trimethylopropane Coconut Ether, Polyether-1, Phenoxyethanol, Butylene Glycol, Iodopropynyl Butylcarbamate, Triethoxycaprylysilane

  • Labeling

    PL007 Artwork.jpg

  • INGREDIENTS AND APPEARANCE
    PRIVATE LABEL MOISTURIZING OIL FREE PARABEN FREE SPF43 
    sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION75 g  in 1000 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75   in 1000 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE25   in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    OCTYL STEARATE (UNII: 772Y4UFC8B)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60232-0007-150 g in 1 BOTTLE; Type 0: Not a Combination Product05/07/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/07/2010
    Labeler - Swiss-American CDMO, LLC (080170933)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(60232-0007)