Label: SKINPHARMACY ADVANCED SUN THERAPY BROAD SPECTRUM SPF 50 FACE- homosalate, oxybenzone, octisalate, avobenzone, octocrylene liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 7, 2017

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

  • Active ingredients

    Avobenzone 3.0%

    Homosalate 10.0%

    Octisalate 5.0%

    Octocrylene 2.0%

    Oxybenzone 6.0%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

    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 cause by the sun.
  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    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:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
  • Inactive ingredients

    Water, Butylene Glycol, PEG-8, Polyethylene, Dimethicone, Silica, Picea Albies Wood Extract, Sodium Ascorbyl Phosphate, Retinyl Palmitate, Tocopherol, Tocopheryl Acetate, Titanium Dioxide, Aloe Barbadensis Leaf Juice, Bentonite, Methyl Glucose Sesquistearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Polyacrylate, Kaolin, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Chlorphenesin, Phenoxyethanol.

    Polargel® is a registered trademark of AMCOL International Corp.

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2016 CVS/pharmacy
    CVS.com®       1-800-SHOP CVS

    Made in the U.S.A. of U.S. and imported components
    V-32991

    CVS® Quality
    Money Back Guarantee

    M050912CP       FP155

  • Principal Display Panel - Carton Label

    SKIN+
    PHARMACY
    ®

    ADVANCED
    SUN
    THERAPY

    BROAD SPECTRUM
    SPF 50 FACE LOTION

    UVA/UVB protection
    with Polargel
    ®
    UV Technology

    Sunscreen with antioxidant
    Vitamin A & Picea Albies
    Wood Extract for protection
    against free radicals

    Polargel® UV Technology
    allows lower sunscreen
    actives & optimizes
    performance
    moisturizing, non-whitening
    formula with broad
    spectrum protection
    water resistant (80 minutes)
    paraben, oil & fragrance free

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    Actual Product Size on Side Panel

    3 FL OZ (90 mL)

    Principal Display Panel - Carton Label
  • Principal Display Panel - Tube Label

    SKIN+PHARMACY®

    ADVANCED
    SUN
    THERAPY

    BROAD SPECTRUM
    SPF 50 FACE LOTION

    UVA/UVB protection
    with Polargel® UV Technology

    Sunscreen with antioxidant Vitamin A
    & Picea Albies Wood Extract for
    protection against free radicals

    Polargel® UV Technology allows
    lower sunscreen actives &
    optimizes performance
    moisturizing, non-whitening formula
    with broad spectrum protection
    water resistant (80 minutes)
    paraben, oil & fragrance free

    DERMATOLOGIST TESTED

    exclusively at

    CVS/pharmacy

    3 FL OZ (90 mL)

    Principal Display Panel - Tube Label
  • INGREDIENTS AND APPEARANCE
    SKINPHARMACY ADVANCED SUN THERAPY BROAD SPECTRUM SPF 50 FACE 
    homosalate, oxybenzone, octisalate, avobenzone, octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) homosalate100 mg  in 1 mL
    oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) oxybenzone60 mg  in 1 mL
    octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) octisalate50 mg  in 1 mL
    avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) avobenzone30 mg  in 1 mL
    octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) octocrylene20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    butylene glycol (UNII: 3XUS85K0RA)  
    polyethylene glycol 400 (UNII: B697894SGQ)  
    high density polyethylene (UNII: UG00KM4WR7)  
    dimethicone (UNII: 92RU3N3Y1O)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    picea abies wood (UNII: 72GZ8K8996)  
    sodium ascorbyl phosphate (UNII: 836SJG51DR)  
    vitamin a palmitate (UNII: 1D1K0N0VVC)  
    tocopherol (UNII: R0ZB2556P8)  
    .alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    bentonite (UNII: A3N5ZCN45C)  
    carbomer copolymer type A (UNII: 71DD5V995L)  
    sodium polyacrylate (8000 mw) (UNII: 285CYO341L)  
    kaolin (UNII: 24H4NWX5CO)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    edetate disodium (UNII: 7FLD91C86K)  
    sodium hydroxide (UNII: 55X04QC32I)  
    chlorphenesin (UNII: I670DAL4SZ)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-021-011 in 1 CARTON04/01/2016
    190 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2016
    Labeler - CVS Health (062312574)
    Registrant - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health & Beauty Solutions, Inc. DBA872684803ANALYSIS(69842-021) , MANUFACTURE(69842-021) , LABEL(69842-021) , PACK(69842-021)