Label: FOTOSKINOX FACE CREAM SUNSCREEN- avobenzone, ensulizole, octinoxate, octocrylene, titanium dioxide cream

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

Drug Label Information

Updated January 15, 2024

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  • Active Ingredient Purpose

    Avobenzone 3%

    Ensulizole 3%

    Octinoxate 4% Sunscreen

    Octocrylene 2%

    Titanium Dioxide 2.6%

  • 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

  • Warnings

    Do not use on damaged or broken skin

  • Warnings

    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 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, regualrly use a sunscreen with a Broad Spectrum SPF value o 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 15C-30C (59F-86F).

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

  • Inactive Ingredients

    Water, Cyclopentasiloxane, Butyl Methoxydibenzoylmethane Ethylhexyl Methoxycinnamate, Dicaprylyl Ehter, Phenylbenzimidazole Sulfonic Acid, Propanediol, Squalane, Ethyl Macadamiate, Butylene Glycol, C8-22 Alkyl Acrylates/methacrylic Acid Crosspolymer, Triethanolamine, Cetyl Alcohol, Glyceryl Stearate, Sodium Polyacrylate, Phenoxyethanol, Glycerin, PEG-75 Stearate, Cetheth-20, Steareth-20, Lecithin, Yellow Iron Oxide (CI 77492), Gossypium Herbaceum Callus Culture, Silica, Ehylhexylglycerin, Red Iron Oxide (CI 77491), Polygonum Aviculare Extract, Glack Iron Oxide (CI 77499), Alteromonas Ferment Extract, Citric Acid, Potassium Sorbate, Sodium Benzoate, Tocopherol, Malic Acid, Acetyl Hexapeptide-49, Fragrance, Citronellol, D-Limonelle, Hydroxycitronellal, Linalool, Geraniol.

  • Questions or comments?

    usa@skymedic.eu

  • OUTER PACKAGING

    50 mL NDC 82601-200-0150 mL NDC 82601-200-01

    Fotoskinox crema COLOR back

  • INGREDIENTS AND APPEARANCE
    FOTOSKINOX FACE CREAM SUNSCREEN 
    avobenzone, ensulizole, octinoxate, octocrylene, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82601-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3 mg  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 mg  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.6 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETETH-20 (UNII: I835H2IHHX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYGONUM AVICULARE WHOLE (UNII: M990N03611)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GOSSYPIUM HERBACEUM FLOWER (UNII: CVM893280N)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SQUALANE (UNII: GW89575KF9)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MALIC ACID (UNII: 817L1N4CKP)  
    ACETYL HEXAPEPTIDE-49 (UNII: 4055X1S509)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    GERANIOL (UNII: L837108USY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82601-200-011 in 1 CARTON06/30/2022
    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 DrugM02006/30/2022
    Labeler - HANS BIOMED S.L. (464035248)
    Registrant - AY CONSULTING SERVICES, LLC (078311971)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANS BIOMED , S.L.464035248manufacture(82601-200)
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