Label: CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 50- octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide lotion

  • NDC Code(s): 0299-4930-02
  • 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 23, 2022

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

  • Active Ingredients.....Purpose

    Octinoxate 7.5% .................Sunscreen
    Octisalate 5% .....................Sunscreen
    Octocrylene 7% ..................Sunscreen
    Oxybenzone 6% .................Sunscreen
    Titanium Dioxide 5.7% ........Sunscreen

  • Uses

    Helps prevent sunburn.

  • Warnings


    Skin Cancer/Skin Aging Alert:

    Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown to help prevent sunburn, not skin cancer or early aging.

    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.

  • Inactive Ingredients

    Water, Propylene Glycol, Glycerin, Dimethicone, VP/Eicosene Copolymer, Cyclomethicone, Stearic Acid, Dimethiconol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Aluminum Hydroxide, Disodium EDTA, Tocopherol, Triethanolamine, Phenoxyethanol, Ethylparaben, Chlorphenesin, Cetyl Alcohol, Carbomer, Methylparaben, Xanthan Gum

  • Other Information

    • Protect this product from excessive heat and direct sun.

  • Questions?

    1-866-735-4137

  • Principal Display Panel - 1.7oz carton

    P54998-1 carton artwork

    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil®

    Daily Facial
    Moisturizer

    with Sunscreen SPF 50

    50+

    Dry to Normal,
    Sensitive Skin

    All day moisturizer hydrates,
    smooths, and protects skin
    from harmful sun exposure

    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

  • INGREDIENTS AND APPEARANCE
    CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 50 
    octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4930
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE57 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4930-021 in 1 CARTON01/01/2012
    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 finalpart35201/01/2012
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4930)