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
  • 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 March 2, 2021

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

  • Active Ingredients.....Purpose

    Avobenzone 2.8% .................Sunscreen
    Homosalate 9.5% .....................Sunscreen
    Octisalate 4.8% ..................Sunscreen
    Octocrylene 7% .................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, ISOPROPYL PALMITATE, SILICA, NIACINAMIDE, CETEARYL OLIVATE, 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, LEONTOPODIUM  (EDELWEISS) EXTRACT, STEARIC ACID, 1,2-HEXANEDIOL, ORYZA SATIVA (RICE) LEES EXTRACT, PROPANEDIOL, SODIUM HYDROXIDE, ADENOSINE, POTASSIUM SORBATE, SODIUM BENZOATE, CITRIC ACID, MYRISTIC ACID, BUDDLEJA DAVIDII (SUMMER LILAC) LEAF EXTRACT, THYMUS VULGARIS (THYME) LEAF EXTRACT, TOCOPHEROL (VITAMIN E)

  • Questions or comments?

    1-866-735-4137

  • Principal Display Panel - 3 FL OZ Carton

    (083215) P55113-0 Cetaphil Daily Face Moist SPF 35 3oz Carton_CLEAN_Artwork

    Cetaphil®

    Daily Oil - Free

    Facial Moisturizer

    with sunscreen

    BROAD SPECTRUM SPF 35
    35

    Combination, sensitive skin

    Lightweight lotion
    hydrates and protects skin
    from sun damage

    Antioxidants & ProVitamin B5 

    Skin Cancer Foundation logo

    3 FL OZ (88mL)


    Distributed by:
    Galderma Laboratories, L.P.
    Fort Worth, Texas
    76177 USA
    All trademarks are the property of their respective owners.
    cetaphil.com
    P55113-0












  • 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)  
    Leontopodium Nivale Subsp. Alpinum Root (UNII: SDW6SS1K6I)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Rice Germ (UNII: 7N2B70SFEZ)  
    Propanediol (UNII: 5965N8W85T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Adenosine (UNII: K72T3FS567)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Myristic Acid (UNII: 0I3V7S25AW)  
    Buddleja Davidii Leaf (UNII: X380815D32)  
    Thymus Vulgaris Leaf (UNII: GRX3499643)  
    Tocopherol (UNII: R0ZB2556P8)  
    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 finalpart35211/01/2020
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(0299-4113)