Label: CETAPHIL SHEER MINERAL FACE LIQUID SUNSCREEN SPF 50- zinc oxide lotion

  • NDC Code(s): 0299-4110-00, 0299-4110-05
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 14, 2023

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  • Active Ingredients

    Zinc Oxide 12% 

  • PURPOSE

    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
  • 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.

  • Directions

    • shake well
    • apply liberally 15 minutes before sun exposure
    • reapply:  
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • children under 6 months of age: Ask a doctor
    • 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 Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses

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



  • Inactive Ingredients

    ALLANTOIN, BISABOLOL, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CAPRYLYL GLYCOL, CAPRYLYL METHICONE, DIMETHICONE, DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, ISODODECANE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, LAURYL PEG-8 DIMETHICONE, NIACINAMIDE, OCTYLDODECYL NEOPENTANOATE, PEG-10, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, PROPANEDIOL, SODIUM CHLORIDE,SODIUM HYDROXIDE, TETRASODIUM GLUTAMATE DIACETATE, TOCOPHEROL (VITAMIN E), TRILAURETH-4 PHOSPHATE, WATER

  • Questions or comments?

    1-866-735-4137

  • PRINCIPAL DISPLAY PANEL - 1.7 FL OZ CARTON

    P55342-1 Cetaphil Sun SPF 50 Liquid Drops 1.7oz carton

    DERMATOLOGIST RECOMMENDED
    FOR SENSITIVE SKIN

    Cetaphil®   SUN  
     50   

    Sheer Mineral Face
    Liquid Sunscreen

    Broad Spectrum SPF 50


    Formulated for sensitive skin

    1.7 FL OZ (50 mL)

    Distributed by:
    Galderma Laboratories, L.P.
    Dallas, TX 75201 USA
    All trademarks are the property of their respective owners.
    cetaphil.com
    P55342-1

    PRINCIPAL DISPLAY PANEL - 1.7 FL OZ FRONT LABEL

    CETAPHIL SUN SPF 50 LIQ bottleFRONT

    Cetaphil®

    SUN
    50

    Sheer Mineral Face
    Liquid Sunscreen
    Broad Spectrum SPF 50
     

    Formulated for sensitive skin
    Microbiome gentle
    Water resistant (80 minutes)
    Ideal for use under makeup
    Vitamin E

    1.7 FL OZ (50mL)
    P55341-1


  • INGREDIENTS AND APPEARANCE
    CETAPHIL SHEER MINERAL FACE LIQUID SUNSCREEN SPF 50 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide120 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    Levomenol (UNII: 24WE03BX2T)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer (450000000 Mw) (UNII: 9KB5R958PB)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Isododecane (UNII: A8289P68Y2)  
    Niacinamide (UNII: 25X51I8RD4)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Polyethylene Glycol 500 (UNII: 761NX2Q08Y)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)  
    Propanediol (UNII: 5965N8W85T)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
    Tocopherol (UNII: R0ZB2556P8)  
    Trilaureth-4 Phosphate (UNII: M96W2OLL2V)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4110-001 in 1 CARTON11/01/2020
    150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0299-4110-0510 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/2020
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044manufacture(0299-4110)
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