Label: IMAGE SKINCARE PREVENTION PLUS DAILY DEFENSE LIP ENHANCER- zinc oxide lip sunscreen cream

  • NDC Code(s): 60232-0027-0
  • Packager: Swiss-American CDMO, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 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 a doctor if rash occurs.  If swallowed, get medical help or contact a Poison Control Center right away.

  • Keep out of Reach of Children

    Keep out of Reach of Children

  • Active Ingredients

    Zinc Oxide   11%   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.

  • 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.

  • Directions For Sunscreen Use

    Apply generously 15 minutes before sun exposure.  Children under 6 months of age: ask a doctor.  Reapply at least every 2 hours.  Use a water resistant sunscreen if swimming or sweating.  Immediately after towel drying.  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 Spectgrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am to 2pm, wear long-sleeved shirts, pants, hats and sunglasses.

  • Other Information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive Ingredients

    hydrogenated polyisobutene, caprylic/capric triglyceride, ethylene/propylene/styrene copolymer, butyloctyl salicylate, octyldodecyl neopentanoate, pentaerythrityl tetraisostearate, isostearic acid, lecithin, polyglyceryl-3 polyricnoleate, polyhydroxystearic acid, ethylhexyl palmitate, bytlene/ethylene/styrene copolymer, aroma, tribehenin, limonene, phenyl trimethicone, ppg-12/smdi copolymer, sorbitan isostearate, silica dimethyl silylate, butylene glycol, pentylene glycol, pentaerythrityl tetra-di-t-butyl hydroxylhydrocinnamate, lacic acid, linalool, sodium chondroitin sulfate, citral, atelocollagen, palmitoyl tripeptide-1, persea gratissma (avocado) oil, diisopropyl dimer dilinoleate, tocopheryl acetate, tocopherol, oryzanol, ubiquinone

  • Questions

    Questions: Call 800-796-7546

  • Labeling

    Prevention Plus

  • INGREDIENTS AND APPEARANCE
    IMAGE SKINCARE PREVENTION PLUS DAILY DEFENSE LIP ENHANCER 
    zinc oxide lip sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION110 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ORYZANOL (UNII: SST9XCL51M)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CITRAL (UNII: T7EU0O9VPP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60232-0027-07 g in 1 TUBE; Type 0: Not a Combination Product01/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/02/2020
    Labeler - Swiss-American CDMO, LLC (080170933)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(60232-0027)
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