Label: CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 50 SUNSCREEN- homosalate, octisalate, octocrylene and zinc oxide lotion

  • NDC Code(s): 49967-263-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 28, 2024

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

  • Active ingredients

    Homosalate 8%

    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 at least every 2 hours 
    • use a water resistant sunscreen if swimming or sweating 
    • Sun Protection Measures. Spending time in the sun increases our 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               

  • Other information

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

    water, glycerin, dimethicone, propanediol, butyloctyl salicylate, steareth-20, cellulose, niacinamide, ehtylhexyl methoxycrylene, steareth-2, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, glycine soja (soybean) oil, triethoxycaprylsilane, cetearyl alcohol, behentriminium methosulfate, triethyl citrate, sodium hyaluronate, sodium lauroryl lactylate, cholesterol, ammonium polyacryloyldimethyl taurate, tocopherol, chlorphenesin, hydroxyacetophenone, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, trisodium ethylenediamine disuccinate, phytosphingosine, xanthan gum, polyhydrostearic acid, polysorbate 60, oryza sativa (rice) bran wax, benzoic acid, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer

  • Question or comments?

    Toll-free number 1-877-768-2915

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 50 SUNSCREEN 
    homosalate, octisalate, octocrylene and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-263
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 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 CATION - UNII:13S1S8SF37) ZINC CATION70 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    RICE BRAN (UNII: R60QEP13IC)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-263-011 in 1 CARTON07/01/2024
    189 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/01/2024
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA PRODUCTS, INC624244349manufacture(49967-263)