Label: CETAPHIL- octocrylene, avobenzone lotion

  • NDC Code(s): 0299-3928-04
  • 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 April 1, 2022

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

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

    Water, Diisopropyl Adipate, Cyclomethicone, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polymethyl Methacrylate, Phenoxyethanol, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Carbomer 940, Disodium EDTA, Triethanolamine.

  • 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

                        

    P55219-1 Cetaphil Daily Facial Moisturizer SPF15 4oz Carton

    #1 DOCTOR RECOMMENDED
    SENSITIVE SKINCARE BRAND

    Cetaphil®          

    Daily Facial
    Moisturizer

    with Sunscreen

    BROAD SPECTRUM SPF 15
    15

    Dry to Normal, Sensitive Skin

    Hydrates and nourishes to
    retain skin's vital moisture
    throughout the day

    UVA/UVB Protection

    Recommended
    Skin Cancer Foundation
    Daily Use

    4 FL OZ (118mL)


    Distributed by:
    Galderma Laboratories, L.P.
    Fort Worth, Texas 76177 USA

    All registered trademarks are the property of their respective owners.


    Made in Canada

    cetaphil.com
    P55219-1

  • 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 (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    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 finalpart35204/01/2000
    Labeler - Galderma Laboratories, L.P. (047350186)
    Establishment
    NameAddressID/FEIBusiness Operations
    G Production Inc.251676961manufacture(0299-3928)