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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 8, 2023

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  • Active Ingredients.....Purpose

    Zinc Oxide 12%  ......................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)
    P55341-0


  • 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 finalpart35211/01/2020
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044manufacture(0299-4110)
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