Label: CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SHEER SUNSCREEN BROAD SPECTRUM SPF 30 FACE AND BODY WATER RESISTANT 80 MINUTES HYBRID FORMULA- homosalate, octisalate, octocrylene, and zinc oxide lotion

  • NDC Code(s): 49967-832-01, 49967-832-02
  • Packager: L'Oreal USA Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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

  • Active ingredients

    Homosalate 6%

    Octisalate 5%

    Octocrylene 5%

    Zinc oxide 7%

  • 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

    For sunscreen use:
    ● apply liberally 15 minutes before sun exposure
    ● reapply:

    • after 80 minutes or swimming or sweating
    • immediately after towl drying
    • at least every 2 hours

    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
    ● children under 6 months of age: Ask a doctor

  • Inactive ingredients


    water, c12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, triethylhexanoin, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethanolamine, silica, poly c10-30 alkyl acrylate, stearic acid, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, cetearyl alcohol, triethoxycaprylylsilane, behentrimonium methosulfate, sodium chloride, salicylic acid, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, aluminum hydroxide, iron oxides, phenoxyethanol, p-anisic acid, chlorphenesin, tocoferol, disodium EDTA, disodium stearoyl glutamate, propylene carbonate, citric acid, caprylyl glycol, capryloyl salicylic acid, caprylic/capric triglyceride, diethylhexyl syringylidenemalonate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, ethylhexylglycerin

  • Other information

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

  • Questions or comments?

    Toll-free number 1-888-768-2915

    www.CeraVe.com

  • PRINCIPAL DISPLAY PANEL

    image of a carton

    image of a carton
  • INGREDIENTS AND APPEARANCE
    CERAVE DEVELOPED WITH DERMATOLOGISTS HYDRATING SHEER SUNSCREEN BROAD SPECTRUM SPF 30 FACE AND BODY WATER RESISTANT 80 MINUTES HYBRID FORMULA 
    homosalate, octisalate, octocrylene, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-832
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE60 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-832-011 in 1 CARTON10/10/2022
    189 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-832-025 mL in 1 TUBE; Type 0: Not a Combination Product10/10/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/10/2022
    Labeler - L'Oreal USA Products, Inc. (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA Products, Inc.624244349MANUFACTURE(49967-832)