Label: FACET DAILY MOISTURIZER SPF 35- avobenzone, octocrylene, octisalate, octinoxate lotion

  • NDC Code(s): 52261-0800-0, 52261-0800-1
  • Packager: Cosco International, 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 September 1, 2022

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  • Drug Facts

    Active Ingredient....................Purpose

    Avobenxone 3.00%..................Sunscreen

    Octocrylene 9.50%..................Sunscreen

    Octilsalate 5.00%....................Sunscreen

    Octinoxate 7.50%....................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.
    • Higher SPF gives more subburn protection
  • Warnings

    For external use only.

    Keep out of reach of children.

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

    When using this product 

    • keep out of eyes.  Rinse with water to remove.

    Do not use

    • on damaged or broken skin.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts.
  • Directions

    • Use only as directed
    • Apply liberally and spread evenly 15 minutes before sun exposure
    • Reapply at least every 2 hours or immediately after towel drying
    • Use a water-resistant sunscreen if swimming or sweating
    • For children under 6 months of age:  Ask a doctor

    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.
  • Inactive Ingredients

    Water, Glyceryl Stearate SE, Alkyl (C12-15) Benzoate, Butyloctyl Salicylate, Capryloyl Glycerin/Sebacic Acid Copolymer, Glyceryl Stearate/PEG-100 Stearate, Cetostearyl Alcohol, Ceteareth 20, Isopropyl Myristate, Dimethicone, Phenoxyethanol, Butylene Glycol, Glycerin, Jojoba Oil, Caprylyl Glycol, Carbomer Interpolymer Type B (Allyl Pentaerythritol Crosslinked), Niacinamide (vitamin B3), Panthenol, Sodium Chloride, Sodium Hydroxide, Sodium Hyaluronate, Hyaluronic Acid

  • Other Information

    • Protect the product in this container from excessuve heat and direct sun
    • Store at temperatures below 90°F
    • May discolor some fabrics.
  • Questions or Comments?

    Call (855) 658-8855

    Distributed by

    Thirty Madison

    New York, NY, 1001

    (855) 658-8855

    Made in USA

  • PRINCIPAL DISPLAY PANEL

    3ml label

  • PRINCIPAL DISPLAY PANEL

    2oz label

  • PRINCIPAL DISPLAY PANEL

    2oz carton

  • INGREDIENTS AND APPEARANCE
    FACET DAILY MOISTURIZER SPF 35 
    avobenzone, octocrylene, octisalate, octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 kg  in 1 kg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 kg  in 1 kg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.095 kg  in 1 kg
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-0800-11 in 1 CARTON09/01/2022
    10.059 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:52261-0800-00.003 kg in 1 PACKET; Type 0: Not a Combination Product09/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/01/2022
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-0800) , label(52261-0800) , pack(52261-0800)
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