Label: CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 49967-150-01, 49967-150-02, 49967-150-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 31, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients

    Titanium dioxide 6%

    Zinc oxide 5%

  • 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

  • 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

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • 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.-2p.m.
    •    wear long-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: Ask a doctor
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    water, glycerin, C12-15 alkyl benzoate, dimethicone, glyceryl stearate, isododecane, butyloctyl salicylate, styrene/acrylates copolymer, propanediol, stearic acid, PEG-100 sterate, sorbitan stearate, niacinamide, acrylates/dimethicone copolymer, PEG-8 laurate, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, cetearyl alcohol, ceteareth-20, triethoxycaprylylsilane, dimethiconol, sodium citrate, sodium lauroyl lactylate, sodium dodecylbenzenesulfonate, myristic acid, sodium hyaluronate, cholesterol, aluminum hydroxide, palmitic acid, phenoxyethanol, chlorphenesin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylyl glycol, citric acid, panthenol, xanthan gum, phytosphingosine, polyhydroxystearic acid, polysorbate 60, ethylhexylglycerin

  • PRINCIPAL DISPLAY PANEL

    image description

    image description
  • INGREDIENTS AND APPEARANCE
    CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PEG-8 LAURATE (UNII: 762O8IWA10)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-150-011 in 1 CARTON02/01/2019
    175 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-150-025 mL in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    3NDC:49967-150-032.5 mL in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/01/2019
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-150)