Label: DAILY FACIAL MOISTURIZER- octinoxate, octisalate, avobenzone lotion

  • 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 May 22, 2020

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  • Active ingredients

    Octinoxate 7.5%

    Octisalate 5.0%

    Avobenzone 3.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the rise 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

  • When using this product

    keep out of eyes.  Rinse with water to remove.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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 the 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 from excessive heat and direct sun
    • may stain some fabrics
  • Inactive ingredients

    water, diisopropyl adipate, cyclomethicone, glycerin, undecylcrylene dimethicone, glyceryl stearate, PET-100 stearate, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, tocopyeryl acetate, carbomer, disodium EDTA, trietanoolamine, potassium sorbate

  • SPL UNCLASSIFIED SECTION

    CVS Health Daily Facial Moisturizer with Broad Spectrum SPF 15 Sunscreen protects against the sun's harmful UVA and UVB rays to help prevent sunburn.

    • non-comedogenic
    • fragrance free
    • dermatologist tested

    CVS Health Daily Facial Moisturizer with Broad Spectrum SPF 15 Sunscreen is a lightweight formula that hydrates and nouruishes while protecting against the sun's harmful rays, with no greasy feel.  Perfect for all skin types.

    *This product is not manufatured or distributed by Galmerma Laboratories, L.P., distributor of Cetaphil Daily Facial Moisturizer SPF 15

    **vs. the 4 fl oz size of Cetaphil Daily Facial Moisturizer

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    www.cvs.com

    1-800-shop-CVS

    Made in the U.S.A. of U.S. and imported components

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    www.cvs.com

    1-800-shop-CVS

    Made in the U.S.A. of U.S. and imported components

    995.001/955AB

  • principal display panel

    20% MORE THAN THE NATIONAL BRAND

    Compare to Cetaphil Daily Facial Moisturizer*

    CVS Health

    Daily Facial Moisturizer

    BROAD SPECTRUM

    SPF 15 SUNSCREEN

    FOR ALL SKIN TYPES

    • Light, non-greasy feel
    • Non-comedogenic
    • Paraben, phthalate & fragrance free
    • UVA/UVB protection

    SPF 15

    4.8 FL OZ (141 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DAILY FACIAL MOISTURIZER 
    octinoxate, octisalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-968
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE76.5 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.0 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-968-26141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/25/2016
    Labeler - CVS Pharmacy (062312574)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(59779-968)
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