Label: CETAPHIL- octocrylene, avobenzone lotion

  • NDC Code(s): 0299-3928-04
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 16, 2024

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  • ACTIVE INGREDIENT

    Avobenzone  3%
    Octocrylene 10%

  • PURPOSE

    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 - 2pm.
    • Wear long-sleeved shirts, pants, hats and sun glasses.
  • INACTIVE INGREDIENTS:

    Water, Diisopropyl Adipate, Cyclopentasiloxane, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polymethyl Methacrylate, Phenoxyethanol, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Carbomer, Disodium EDTA, Sodium Hydroxide

  • Other Information

    • Protect this product from excessive heat and direct sun.
    • May stain some fabrics.

  • Questions?

    1-866-735-4137

  • PRINCIPAL DISPLAY PANEL - 4 FL OZ Carton

                        

    P57752-0 new carton

    NEW LOOK

    Cetaphil®          

    Daily Facial
    Moisturizer
    AM

    15 BROAD SPECTRUM
         SPF 15 (UVA/UVB)
         SUNSCREEN

    All Skin Types

    Ultra lightweight lotion hydrates
    and protects skin

    Glycerin

    Oil-Free

    Recommended
    Skin Cancer Foundation
    Daily Use

    4 FL OZ (118 mL)


    Distributed by:
    Galderma Laboratories, L.P.
    Dallas, TX 75201 USA

    All trademarks are the property of their respective owners.


    Made in Canada

    cetaphil.com
    P57752-0

  • INGREDIENTS AND APPEARANCE
    CETAPHIL 
    octocrylene, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-3928
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    Poly(Methyl Methacrylate; 450000 Mw) (UNII: Z47NNT4J11)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Acrylates/C10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.S) (UNII: 8Z5ZAL5H3V)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-3928-041 in 1 CARTON04/01/2000
    1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/01/2000
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-3928)
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