Label: CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN- homosalate, meradimate, octinoxate, zinc oxide, and octocrylene lotion

  • NDC Code(s): 49967-015-01, 49967-015-02, 49967-015-03, 49967-015-04, view more
    49967-015-05, 49967-015-06
  • Packager: L'Oreal USA Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 30, 2022

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  • Active ingredients

    Homosalate 10%

    Meradimate 5%

    Octinoxate 5%

    Octocrylene 2%

    Zinc oxide 6.3%

  • 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

  • Inactive ingredients

    water, niacinamide, cetearyl alcohol, glycerin, dimethicone, behentrimonium methosulfate, ceramide 3,  ceramide 6-II, ceramide 1, hyaluronic acid, sodium hydroxide, aluminum starch octenylsuccinate, hydroxyethylcellulose, methylparaben, disodium EDTA, propylparaben, sodium lauroyl lactylate, phytosphingosine, cholesterol, carbomer, xanthan gum

  • 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

  • INGREDIENTS AND APPEARANCE
    CERAVE AM FACIAL MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN 
    homosalate, meradimate, octinoxate, zinc oxide, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
    MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE50 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate50 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene20 mg  in 1 mL
    Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide63 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-015-011 in 1 CARTON08/03/2017
    189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:49967-015-021 in 1 CARTON08/03/2017
    260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:49967-015-035 mL in 1 TUBE; Type 0: Not a Combination Product08/03/2017
    4NDC:49967-015-041.5 mL in 1 PACKET; Type 0: Not a Combination Product08/03/2017
    5NDC:49967-015-051 in 1 CARTON08/03/2017
    550 mL in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:49967-015-061 in 1 CARTON08/03/2017
    6148 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/03/2017
    Labeler - L'Oreal USA Products, Inc. (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA Products, Inc.624244349MANUFACTURE(49967-015) , pack(49967-015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc.078717086pack(49967-015)
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