Label: PRIVATE LABEL SUPER LIGHT OIL-FREE SPF45- 2.75% octinsalate, 7.50% octinoxate, 8.00% zinc oxide sunscreen lotion

  • NDC Code(s): 60232-0008-2
  • Packager: Swiss-American CDMO, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

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

  • Use 

    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.

  • Use

    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.

  • Directions

    Apply liberally 15 minutes before sun exposure. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. to 2p.m. Wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor.

  • Keep out of reach of children

    Keep out of reach of children

  • Active Ingredients

    Octinoxate 7.50%

    Octisalate 2.75%

    Zinc Oxide 8.00%

  • Inactive Ingredients

    Ascorbyl Palmitate, Butylene Glycol, Citric Acid, Cyclopentasiloxane, Sodium Hyaluronate, Hydroxyethyl Acrylate/Sodium Acrylouldimethyl Taurate Copolymer, Idodopropynyl Butylcarbamate, Octyldodecyl neopentanoate, Oleth-3 Phosphate, PEG-7 Triethylolpropane Coconut Ether, Phenoxyethanol, Polyisobutene, Purified Water, Retinyl Palmitate, Triethocycaprylysilane

  • Labeling

    PL008 Artwork

  • INGREDIENTS AND APPEARANCE
    PRIVATE LABEL SUPER LIGHT OIL-FREE SPF45 
    2.75% octinsalate, 7.50% octinoxate, 8.00% zinc oxide sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE27.5 g  in 1000 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75.0 g  in 1000 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80.0 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60232-0008-260 g in 1 BOTTLE; Type 0: Not a Combination Product03/22/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/22/2011
    Labeler - Swiss-American CDMO, LLC (080170933)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(60232-0008)
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