Label: CETAPHIL HEALTHY RENEW DAY CREAM BROAD SPECTRUM SPF 30- homosalate, octocrylene, octisalate, avobenzone lotion

  • NDC Code(s): 0299-4136-00
  • Packager: Galderma Laboratories, L.P.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • Active Ingredients.....Purpose

    Homosalate 9.5% .................Sunscreen
    Octocrylene 9.5% .........… Sunscreen
    Octisalate 4.8% ...............…   Sunscreen
    Avobenzone 2.8% ................. Sunscreen

  • 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, BUTYLOCTYL SALICYLATE, SILICA, BEESWAX, NIACINAMIDE, CETEARYL OLIVATE, SODIUM STEAROYL LACTYLATE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PALMITIC ACID, ETHYLHEXYLGLYCERIN, LEONTOPODIUM ALPINUM EXTRACT, STEARIC ACID, 1,2-HEXANEDIOL, ORYZA SATIVA (RICE) LEES EXTRACT, SODIUM HYDROXIDE, PROPANEDIOL, ADENOSINE, CITRIC ACID, HYDROLYZED SOY FLOUR, BUDDLEJA DAVIDII EXTRACT, THYMUS VULGARIS (THYME) EXTRACT

  • Questions or comments?

    1-866-735-4137

  • Principal Display Panel - 1.7 OZ Carton

    P57224-1 carton

    RETINOL ALTERNATIVE

    Dermatologist Recommended
    For Sensitive Skin

    Cetaphil®

    HEALTHY RENEW

    Day Cream
    Broad Spectrum
    SPF 30
    Purified Peptides
    Hydrates to visibly smooth the
    look of fine lines and protects
    from damaging UV rays

    Five Skin Sensitivity Signs

    NET WT 1.7 OZ (48 g)

    Distributed by:
    Galderma Laboratories, L.P., Dallas, TX 75201 USA
    All trademarks are the property of their respective owners.
    cetaphil.com  
    P57224-1











  • INGREDIENTS AND APPEARANCE
    CETAPHIL HEALTHY RENEW DAY CREAM BROAD SPECTRUM SPF 30 
    homosalate, octocrylene, octisalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4136
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate95 mg  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene95 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate48 mg  in 1 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone28 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dipropylene Glycol (UNII: E107L85C40)  
    Panthenol (UNII: WV9CM0O67Z)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Niacinamide (UNII: 25X51I8RD4)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Sodium Stearoyl Lactylate (UNII: IN99IT31LN)  
    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)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Propanediol (UNII: 5965N8W85T)  
    Adenosine (UNII: K72T3FS567)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Hydrolyzed Soy Protein (Enzymatic; 2000 Mw) (UNII: 1394NXB9L6)  
    Buddleja Davidii Whole (UNII: 8JZ8B2V1OV)  
    Thyme (UNII: CW657OBU4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4136-001 in 1 CARTON04/12/2023
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/12/2023
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    ENGLEWOOD LAB, INC.172198223manufacture(0299-4136)
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