Label: CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 35- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 0299-4113-05
  • 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

    Avobenzone 2.8%
    Homosalate 9.5%
    Octisalate 4.8%
    Octocrylene 7%

  • 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

    • 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 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
    • may stain or damage some fabrics
  • Inactive Ingredients

    Water, Glycerin, Dipropylene Glycol, Panthenol (Vitamin B5), Ethylhexyl Methoxycrylene, lsopropyl Palmitate, Silica, Niacinamide, Cetearyl 0livate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E Acetate), Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Palmitic Acid, Ethylhexylglycerin, Stearic Acid, Leontopodium Alpinum Flower/Leaf Extract, 1,2-Hexanediol, Oryza Saliva (Rice) Lees Extract, Propanediol, Sodium Hydroxide, Adenosine, Citric Acid, Myristic Acid, Tocopherol (Vitamin E), Buddleja Davidii (Summer Lilac) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract

  • Questions or comments?

    1-866-735-4137

  • Principal Display Panel - 3 FL OZ Carton

    DFW SPF 35 carton revive

    NEW LOOK

    Cetaphil®

    Daily Facial
    Moisturizer
    AM

    35 BROAD SPECTRUM
         SPF 35 (UVA/UVB)
         SUNSCREEN

    All Skin Types

    Lightweight lotion
    hydrates and protects skin

    Antioxidants, Vitamin B5 

    Oil-Free

    Skin Cancer Foundation logo

    3 FL OZ (88 mL)


    Distributed by:
    Galderma Laboratories, L.P.
    Dallas, Texas 75201 USA
    All trademarks are the property of their respective owners.
    cetaphil.com
    P56561-2











  • INGREDIENTS AND APPEARANCE
    CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 35 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone28 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate95 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate48 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dipropylene Glycol (UNII: E107L85C40)  
    Panthenol (UNII: WV9CM0O67Z)  
    Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Niacinamide (UNII: 25X51I8RD4)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Palmitic Acid (UNII: 2V16EO95H1)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Leontopodium Nivale Subsp. Alpinum Flowering Top (UNII: QQC1AK06RK)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Rice Germ (UNII: 7N2B70SFEZ)  
    Propanediol (UNII: 5965N8W85T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Adenosine (UNII: K72T3FS567)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Myristic Acid (UNII: 0I3V7S25AW)  
    Tocopherol (UNII: R0ZB2556P8)  
    Buddleja Davidii Leaf (UNII: X380815D32)  
    Thymus Vulgaris Leaf (UNII: GRX3499643)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4113-051 in 1 CARTON11/01/2020
    188 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 DrugM02011/01/2020
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    ENGLEWOOD LAB, INC.172198223label(0299-4113) , manufacture(0299-4113) , pack(0299-4113)
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