Label: FOTOSKINOX COLOR FACE CREAM SUNSCREEN BROAD SPECTRUM SPF 50- sunscreen cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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

  • Active Ingredient Purpose

    Avobnzone 3% Sunscreen

    Ensulizole 3% Sunscreen

    Octinoxate 4% Sunscreen

    Octocrylene 2% Sunscreen

    Titanium Dioxide 4.8% Sunscreen

  • Purpose

    Sunscreen

  • Uses

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

    For external use only

  • DO NOT USE

    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.

  • 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 your risk of skin cancer and early skin aging. To decrease this risk, reguarlry 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 10 a.m. to 2 p.m.
    • Wear long-sleeved shirts, pants, hats and, sunglasses.

    Children under 6 months of age. Ask a doctor.

  • Other Information

    Store at 15ºC-30ºC (59ºF-86ºF)

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

  • Inactive Ingredients

    Water, Cyclopentasiloxane, Titanium Dioxide (CI 77891), Dicaprylyl Ether, Propanediol, Squalane, Ethyl Macadamiate, Butylene Glycol, Triethanolamine, Poly C10-30 Alkyl Acrylate, Sodium Polyacrylate, Cetyl Alcohol, Glyceryl Stearate, Phenoxyethanol, Yellow Iron Oxide (CI 77492), Glycerin, Cellulose Acetate, Red Iron Oxide (CI 77491), PEG-75 Stearate, Acrylates/Ammonium Methacrylate Copolymer, Propylene Glycol Stearate, Ceteth-20, Steareth-20, Lecithin, Gossypium Herbaceum Callus Culture, Silica, Ethylhexylglycerin, Magnesium Stearate, Black Iron Oxide (CI 77499), Polygonum Aviculare Extract, Hydrogenated Polydecene, Alteromonas Ferment Extract, Potassium Sorbat, Sodium Benzoate, Trideceth-6, Tocopherol, Citric Acid, Malic Acid, Acetyl Hexapeptide-49, Fragrance, Citronellol, D-Limonene, Geraniol, Linalool.

  • Questions or comments?

    usa@skymedic.eu

  • OUTER PACKAGING

    50 mL NDC 82601-300-01

    back packaging fotoskinox crema COLOR back

  • INGREDIENTS AND APPEARANCE
    FOTOSKINOX COLOR FACE CREAM SUNSCREEN BROAD SPECTRUM SPF 50 
    sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82601-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3 mg  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 mg  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.8 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    SQUALANE (UNII: GW89575KF9)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
    GERANIOL (UNII: L837108USY)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETETH-20 (UNII: I835H2IHHX)  
    GOSSYPIUM HERBACEUM FLOWER (UNII: CVM893280N)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYGONUM AVICULARE WHOLE (UNII: M990N03611)  
    HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)  
    ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)  
    MALIC ACID (UNII: 817L1N4CKP)  
    ACETYL HEXAPEPTIDE-49 (UNII: 4055X1S509)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82601-300-011 in 1 CARTON07/01/2022
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/01/2022
    Labeler - HANS BIOMED S.L. (464035248)
    Registrant - AY CONSULTING SERVICES, LLC (078311971)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANS BIOMED, S.L.464035248manufacture(82601-300)