Label: CLINICAL SKIN FILTER TINTED SUNSCREEN MEDIUM DARK cream

  • NDC Code(s): 84755-0004-1
  • Packager: KRX RESOURCES SDN. BHD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 23, 2024

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

  • DOSAGE & ADMINISTRATION

    Use fingertips and apply all over face and neck, Apply liberally before sun exposure and reapply after 60 minutes of swimming and/or sweating.

  • WARNINGS

    Warning:
    Spending time under the sun for
    long period time increases your risk of skin cancer and early signs of ageing.
    External Use Only.
    If Irritation occurs, stop using and
    consult your doctor.
    Keep out of reach of children.
    If product is swallowed, get medical help or contact poison control immediately.

  • INACTIVE INGREDIENT


    Inactive Ingredients:

    Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, Titanium Dioxide, Ethylhexyl Salicylate, Zinc Oxide, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Octocrylene, Cetyl PEG/PPG-10/1 Dimethicone,
    Glycerin, Methylpropanediol, Niacinamide, 1,2- Hexanediol, Dimethicone, Disteardimonium Hectorite, Sorbitan Olivate, Sorbitan Sesquioleate, Microcrystalline Wax, Lauroyl Lysine, Magnesium Sulfate, PEG-30 Dipolyhydroxystearate, Quaternium-18 Bentonite, CI 77492, Silica, Triethoxycaprylylsilane, CI 77491, Crataegus Cuneata Fruit Extract, Prunus Persica (Peach) Fruit Extract, Pyrus Communis (Pear) Fruit Extract, Ethylhexylglycerin, CI 77499, Adenosine, Hedera Helix (Ivy) Extract, Vanilla Planifolia Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Disodium EDTA, BHT, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate.

  • INDICATIONS & USAGE

    Our CLINICAL SKIN FILTER Mineral Tinted Sunscreen does not leave a white cast, dries on matte, blurs the pores and just leaves skin smooth and photo ready!
    The tint blends in, and It feels like a second skin, It is also water resistant, and helps skin recover from existing sun damage.
    It can be used under make up without leaving clumped and patchy areas. This product is really like no other, and you will love every application.
    -Pore Blurring -Ultra Matte
    -Non Comedogenic
    -White Cast cancellation -Picture perfect
    CRUELTY FREE.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

    FOR ALL SKIN TYPES WATER & SWEAT RESISTANT (60 MINUTES)

    CLINICAL SKIN FILTER Mineral Tinted Sunscreen
    TRANSLUCENT Light/Medium

    Directions:
    Use fingertips and apply all over face and neck, Apply liberally before sun exposure and reapply after 60
    minutes of swimming and/or sweating.

  • ACTIVE INGREDIENT

    Active:
    Cyclopentasiloxane -8%
    Titanium Dioxide - 5.78%
    Zinc Oxide - 3.94%
    Octocrylene -3%

  • PRINCIPAL DISPLAY PANEL

    CLINICAL SKIN FILTER Mineral Tinted Sunscreen TRANSLUCENT Medium/Dark

    Content of Labeling

  • INGREDIENTS AND APPEARANCE
    CLINICAL SKIN FILTER TINTED SUNSCREEN MEDIUM DARK 
    clinical skin filter tinted sunscreen medium dark cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84755-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.182 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.734 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.9 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PENTAMETHYL CYCLOPENTASILOXANE (UNII: K29QC5YCW8)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CRATAEGUS CUNEATA FRUIT (UNII: 98TEA9T639)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    QUATERNIUM-18 (UNII: O7757NO1VL)  
    PYRUS COMMUNIS WHOLE (UNII: 80UKV9Y4B3)  
    HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    POTASSIUM MAGNESIUM SULFATE (UNII: YI4N487572)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PRUNUS PERSICA FRUITING TOP (UNII: U08429QT99)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    VANILLA PLANIFOLIA WHOLE (UNII: BOS0R5Y21O)  
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84755-0004-130 mL in 1 PACKAGE; Type 0: Not a Combination Product09/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2024
    Labeler - KRX RESOURCES SDN. BHD. (813058498)
    Registrant - KRX RESOURCES SDN. BHD. (813058498)
    Establishment
    NameAddressID/FEIBusiness Operations
    KRX RESOURCES SDN. BHD.813058498manufacture(84755-0004)