Label: CERAVE DEVELOPED WITH DERMATOLOGISTS BABY MOISTURIZING- dimethicone cream

  • NDC Code(s): 49967-805-01, 49967-805-02
  • Packager: L'Oreal USA Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 29, 2024

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  • Active ingredients

    Dimethicone 1.2%

  • Purpose

    Skin protectant

  • Uses

    • temporarily protects and helps relieve chafed, chapped or cracked skin
    • helps protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    When using this product do not get into eyes

    Stop use and ask a doctor if

    •
    condition worsens
    •
    symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    •
    deep or puncture wounds
    •
    animal bites
    •
    serious burns
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply as needed

  • Inactive ingredients

    water, glycerin, cetearyl alcohol, caprylic/capric triglycerides, cetyl alcohol, ceteareth-20, petrolatum, ceramide 3, ceramide 6-II, ceramide 1, hyaluronic acid, cholesterol, phenoxyethanol, behentrimonium methosulphate, potassium phosphate, dipotassium phosphate, ethylhexylglycerin, sodium lauroyl lactylate, disodium EDTA, phytosphingosine, carbomer, xanthan gum, sodium hydroxide

  • Questions?

    Toll-free number 1-888-768-2915

    www.cerave.com

  • PRINCIPAL DISPLAY PANEL

    image of a label

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  • INGREDIENTS AND APPEARANCE
    CERAVE DEVELOPED WITH DERMATOLOGISTS BABY MOISTURIZING 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE12 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)  
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-805-01142 g in 1 TUBE; Type 0: Not a Combination Product09/15/201705/31/2024
    2NDC:49967-805-0214.2 g in 1 TUBE; Type 0: Not a Combination Product09/15/201705/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/15/201705/31/2024
    Labeler - L'Oreal USA Products Inc. (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA Products, Inc.624244349MANUFACTURE(49967-805)
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