Label: PRIVATE LABEL SPF45 WATER RESISTANT PARABEN FREE SUNSCREEN- octinoxate, octisalate, zinc oxide sunscreen lotion

  • NDC Code(s): 60232-0006-1
  • Packager: Swiss-American CDMO, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 7, 2023

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  • 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 physician if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    Helps prevent sunburn. If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

  • Uses

    Helps prevent sunburn. If used as directed with other sun protection measures (See Directions), decrease the risk of skin cancer and early skin aging caused by the sun

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and 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 this risk, regularly use a sunscreen with a broad-spectrum SPF 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-sleeve shirts, pants, hats and sunglasses. Before use on children under 6 months, ask a physician.

  • Keep Out of Reach of Children

    Keep Out of Reach of Children

  • Active Ingredients

    Zinc Oxide 8.0%, Octinoxate 7.5%, Octisalate 3.0%

  • Inactive Ingredients

    Ascorbyl Palmitate, Butylene Glycol, Cylcopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexyl Isonnonanoate, Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Retinyl Palmitate, Sodium Chloride, Triethyoxycaprylylsilane

  • Labeling

    PL006 Artwork

  • INGREDIENTS AND APPEARANCE
    PRIVATE LABEL SPF45 WATER RESISTANT PARABEN FREE SUNSCREEN 
    octinoxate, octisalate, zinc oxide sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 g  in 1000 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 g  in 1000 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60232-0006-150 g in 1 BOTTLE; Type 0: Not a Combination Product08/31/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/31/2011
    Labeler - Swiss-American CDMO, LLC (080170933)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(60232-0006)
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