Label: CETAPHIL OIL ABSORBING SPF 30- avobenzone, octisalate, octocrylene lotion

  • NDC Code(s): 0299-4134-00, 0299-4134-05
  • 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 June 16, 2022

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  • Active ingredients......Purpose

    AVOBENZONE 3%......Sunscreen
    OCTISALATE 5%........Sunscreen
    OCTOCRYLENE 7%....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 sunglasses.

  • Inactive Ingredients

    Allantoin, Aluminum Starch Octenylsuccinate, Caprylyl Glycol, Carbomer, Ceramide NP, Diisopropyl Sebacate, Dimethicone, Dimethiconol, Disodium EDTA, Glycerin, Glycyrrhetinic Acid, Isopropyl Lauroyl Sarcosinate, Panthenol, Pentylene Glycol, Phenoxyethanol, Polymethyl Methacrylate, Polysorbate 61, Potassium Sorbate, Silica, Sodium Stearoyl Glutamate, Sucrose Tristearate, Tocopheryl Acetate, Triethanolamine, Water, Xanthan Gum, Zinc Gluconate

  • Other Information

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

    1-866-735-4137

    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

  • PRINCIPLE DISPLAY PANEL - 4oz carton


    #1 Doctor Recommended
    Sensitive Skincare Brand

    Cetaphil®


    DERMACONTROLTM

    Oil Absorbing Moisturizer

    with sunscreen

    BROAD SPECTRUM SPF 30

    Oily, Sensitive Skin

    Clinically proven to reduce shine
    and hydrate without irritation with
    added UVA/UVB protection

    Mattifying & Soothing
    Zinc Technology

    Skin Cancer Foundation logo
    4 FL OZ (118 mL)

    P55322-2

    052015 P55322-2 Cet Oil Absorbing Moist SPF 30 4oz carton
  • INGREDIENTS AND APPEARANCE
    CETAPHIL OIL ABSORBING SPF 30 
    avobenzone, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)  
    Ceramide Np (UNII: 4370DF050B)  
    Diisopropyl Sebacate (UNII: J8T3X564IH)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dimethiconol (2000 Cst) (UNII: T74O12AN6Y)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Enoxolone (UNII: P540XA09DR)  
    Isopropyl Lauroyl Sarcosinate (UNII: LYR06W430J)  
    Panthenol (UNII: WV9CM0O67Z)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Poly(Methyl Methacrylate; 450000 Mw) (UNII: Z47NNT4J11)  
    Polysorbate 61 (UNII: X9E1MY2JQG)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
    Sucrose Tristearate (UNII: 71I93STU5M)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Trolamine (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Zinc Gluconate (UNII: U6WSN5SQ1Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0299-4134-001 in 1 CARTON06/01/2022
    1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:0299-4134-0510 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2022
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-4134)
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