Label: CETAPHIL REDNESS RELIEVING DAILY FACIAL MOISTURIZER WITH SUNSCREEN SPF 20- titanium dioxide, zinc oxide cream

  • NDC Code(s): 0299-5889-00, 0299-5889-05
  • 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 April 1, 2022

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

  • Active Ingredients

    Titanium Dioxide 10.1%
    Zinc Oxide 7.8 %

  • Purpose

    Titanium Dioxide ..........Sunscreen
    Zinc Oxide ...................Sunscreen

  • Use(s)

    • 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.
    Stop use and ask a doctor if rash occurs.
    When using this product, keep out of eyes.
    Rinse with water to remove.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours.
    • Children under 6 months: ask a doctor
    SUN PROTECTION MEASURES: Spending time in the sun increases your risk of 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 10am – 2 pm.
    • Wear long-sleeved shirts, pants, hats, and sun glasses.

  • Other Information

    • Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    ALLANTOIN, BENZYL ALCOHOL, C12-15 ALKYL BENZOATE, CAFFEINE, CAPRYLYL METHICONE, CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY) SILYLETHYL DIMETHICONE, CHROMIUM OXIDE GREENS, DICAPRYLYL CARBONATE, DIMETHICONE, DIPOTASSIUM GLYCYRRHIZATE, ETHYLHEXYLGLYCERIN, GLYCERIN, HYDROGENATED LECITHIN, IRON OXIDES, ISOHEXADECANE, MAGNESIUM SULFAGE, MEHYLPROPANEDIOL, SILICA, TOCOPHEROL, TRIETHOXYCAPRYLYLSILANE, TRISILOXANE, WATER

  • Questions?

    1-866-735-4137

  • PRINCIPAL DISPLAY PANEL - 1.7 FL OZ (50 mL) carton

    (051703) P55123-2 Cet Redness Relieving DFM SPF20 1.7oz Carton2

    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil®

    REDNESS
    RELIEVING

    Daily Facial
    Moisturizer
    with Sunscreen
    BROAD SPECTRUM SPF 20
    20

    Redness-Prone,
    Sensitive Skin

    Tinted formula
    neutralizes the
    appearance of redness
    Soothing Allantoin &
    Vitamin E

    5 Skin Sensitivity Signs

    1.7 FL OZ (50 ML)

    Distributed by:
    Galderma Laboratories, L.P.
    Fort Worth, TX 76177 USA
    All trademarks are the property of their
    respective owners.
    Made in Canada
    cetaphil.com
    P55123-2

  • INGREDIENTS AND APPEARANCE
    CETAPHIL REDNESS RELIEVING DAILY FACIAL MOISTURIZER WITH SUNSCREEN SPF 20 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-5889
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE101 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE78 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-5889-001 in 1 CARTON12/09/2016
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0299-5889-0510 mL in 1 TUBE; Type 0: Not a Combination Product12/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/09/2016
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Knowlton Development Corporation Inc.204006464manufacture(0299-5889)