Label: CELL FUSION C LASER SUNSCREEN- zinc oxide, homosalate, octisalate, titanium dioxide cream

  • NDC Code(s): 52554-1200-1, 52554-1200-2
  • Packager: CMS LAB Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2024

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

  • Active ingredients

    Active ingredients:

    ZINC OXIDE 12.70%
    HOMOSALATE 7.50%
    ETHYLHEXYL SALICYLATE 4.50%
    TITANIUM DIOXIDE 2.20%

  • Purpose

    Sunscreen

  • Uses

    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

    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. 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions


    For sunscreen use:
    ■ 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 you 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 10a.m.-2p.m.
    ■ wear long-sleeved shirts, pants, hats, and sunglasses
    ■ children under 6 months of age : Ask a doctor

  • Inactive ingredients

    Inactive ingredients

    Water, Cyclopentasiloxane, Dipropylene Glycol, Disiloxane, Lauryl Peg-10 Tris(Trimethylsiloxy)Silylethyl Dimethicone, Glycerin, Butyloctyl Salicylate, Silica, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, 1,2-Hexanediol, Triethoxycaprylylsilane, Stearic Acid, Aluminum Hydroxide, Sorbitan Caprylate, Dimethicone/Peg-10/15 Crosspolymer, Lavandula Angustifolia (Lavender) Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Glyceryl Caprylate, Ethylhexylglycerin, Sodium Citrate, Hydroxydecyl Ubiquinone,
    Hydrolyzed Collagen, Tocopherol, Hydrogenated Lecithin, Ceramide Np, Sucrose Stearate, Cholesterol, Cholesteryl Macadamiate, Palmitic Acid,
    Biosaccharide Gum-4, Saccharide Isomerate, Hydrolyzed Lupine Protein

  • Other Information

    Other Information
    protect the product in this container from excessive heat and direct sun

  • Questions

    Questions?


    +82 080-447-1820;
    Outside US, dial collect 212-804-7608
    www.cellfusionc.co.kr

    Dist. by Dkcos
    20 W 33rd St New York, NY 10001
    www.dkcos.com

    CMS LAB Inc.
    Made in Korea
    www.cellfusionc.co.kr

  • Package Label: Cell Fusion C Laser Sunscreen SPF50+ 10mL

    Image of carton

  • Package Label: Cell Fusion C Laser Sunscreen SPF50+ 50mL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CELL FUSION C LASER SUNSCREEN 
    zinc oxide, homosalate, octisalate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-1200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12.7 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    IDEBENONE (UNII: HB6PN45W4J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CHOLESTERYL MACADAMIATE (UNII: DFP79OD7KP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52554-1200-110 mL in 1 CARTON; Type 0: Not a Combination Product05/01/202012/31/2024
    2NDC:52554-1200-250 mL in 1 CARTON; Type 0: Not a Combination Product05/01/202012/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/202012/31/2024
    Labeler - CMS LAB Inc. (557795012)
    Registrant - CMS LAB Inc. (557795012)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(52554-1200)