Label: CERAVE DEVELOPED WITH DERMOTOLOGISTS ULTRA LIGHT MOISTURIZING BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate and octocrylene lotion

  • NDC Code(s): 49967-517-01, 49967-517-02
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2023

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

  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 2.7%

  • 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 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
  • Other Information

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

  • Inactive ingredient

    water, C12-15 alkyl benzoate, glyceryl stearate SE, methyl methacrylate crosspolymer, glycerin, pentylene glycol, ceramide NP (ceramide 3), ceramide AP (ceramide 6-II), ceramide EOP (ceramide 1), phytosphingosine, sodium acryloyldimethyltaurate/VP crosspolymer, sodium lauroyl lactylate, cholesterol, xanthan gum, carbomer, hydroxyacetophenone, disodium EDTA, citric acid, sodium hyaluronate

  • Questions or comments?

    Toll-free number 1-888-768-2915

  • PRINCIPAL DISPLAY PANEL

    image description

    image description
  • INGREDIENTS AND APPEARANCE
    CERAVE DEVELOPED WITH DERMOTOLOGISTS ULTRA LIGHT MOISTURIZING BROAD SPECTRUM SPF 30 
    avobenzone, homosalate, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-517
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE27 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-517-011 in 1 CARTON01/22/2018
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-517-025 mL in 1 TUBE; Type 0: Not a Combination Product01/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/22/2018
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, LLC061595175manufacture(49967-517) , pack(49967-517)