Label: AGE RENEWAL FIRMING- octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide lotion

  • NDC Code(s): 68634-063-01
  • Packager: AMCOL Health & Beauty Solutions, Inc. DBA
  • 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 October 7, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 6.0%

    Octisalate 5.0%

    Oxybenzone 4.0%

    Titanium Dioxide 3.9%

    Zinc Oxide 2.0%

  • 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
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: 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
  • Other information

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

    Water, Glyceryl Stearate, Caprylic/Capric Triglyceride, Glycerin, Isopropyl Myristate, Octyldodecyl Neopentanoate, Cetyl Alcohol, Sodium Cetearyl Sulfate, Squalane, Dimethicone, Phenoxyethanol, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cetearyl Glucoside, Xanthan Gum, Chlorphenesin, Bentonite, Retinol, Polysorbate 20, Sodium Polyacrylate, BHT, Picea Abies Wood Extract, Ethylhexylglycerin, Sodium Borate, Silica, Panthenol, Polyhydroxystearic Acid, Arginine, Tocopheryl Acetate, Alumina, Copper Tripeptide-1, Hydrolyzed Soy Protein, Glycine, Sorbitol, Ascorbic Acid, Disodium EDTA, Propyl Gallate

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    © 2012 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

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

    V-13649

    CVS® Quality

    Money Back Guarantee

    FP104

    M050617

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Age Renewal Firming & Hydrating Moisturizer Carton Label

    CVS
    pharmacy®

    age renewal

    firming
    & hydrating
    moisturizer

    SPF 30

    Broad Spectrum SPF 30 Sunscreen

    90% saw reduction in
    the appearance of fine lines

    With retinol SR & copper

    Dermatologist tested

    Paraben free

    UVA/UVB protection

    Compare to Neutrogena®

    Ageless Intensives® Firming Moisture*

    NET WET 1.8 OZ (51 g)

    Principal Display Panel - Age Renewal Firming & Hydrating Moisturizer Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Age Renewal Firming & Hydrating Moisturizer Label

    CVS pharmacy®

    age renewal

    firming
    & hydrating
    moisturizer

    SPF 30

    Broad Spectrum SPF 30 Sunscreen

    90% saw reduction in
    the appearance of fine lines

    With retinol SR & copper

    Dermatologist tested

    Paraben free

    UVA/UVB protection

    NET WET 1.8 OZ (51 g)

    Principal Display Panel - Age Renewal Firming & Hydrating Moisturizer Label
  • INGREDIENTS AND APPEARANCE
    AGE RENEWAL FIRMING 
    octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68634-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate60 mg  in 1 g
    octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate50 mg  in 1 g
    oxybenzone (UNII: 95OOS7VE0Y) (oxybenzone - UNII:95OOS7VE0Y) oxybenzone40 mg  in 1 g
    titanium dioxide (UNII: 15FIX9V2JP) (titanium dioxide - UNII:15FIX9V2JP) titanium dioxide39 mg  in 1 g
    zinc oxide (UNII: SOI2LOH54Z) (zinc oxide - UNII:SOI2LOH54Z) zinc oxide20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    medium-chain triglycerides (UNII: C9H2L21V7U)  
    glycerin (UNII: PDC6A3C0OX)  
    isopropyl myristate (UNII: 0RE8K4LNJS)  
    cetyl alcohol (UNII: 936JST6JCN)  
    octyldodecyl neopentanoate (UNII: X8725R883T)  
    sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)  
    dimethicone (UNII: 92RU3N3Y1O)  
    squalane (UNII: GW89575KF9)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)  
    cetearyl glucoside (UNII: 09FUA47KNA)  
    xanthan gum (UNII: TTV12P4NEE)  
    chlorphenesin (UNII: I670DAL4SZ)  
    bentonite (UNII: A3N5ZCN45C)  
    retinol (UNII: G2SH0XKK91)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    sodium polyacrylate (8000 mw) (UNII: 285CYO341L)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    picea abies wood (UNII: 72GZ8K8996)  
    sodium borate (UNII: 91MBZ8H3QO)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    panthenol (UNII: WV9CM0O67Z)  
    polyhydroxystearic acid (2300 mw) (UNII: YXH47AOU0F)  
    arginine (UNII: 94ZLA3W45F)  
    .alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8)  
    aluminum oxide (UNII: LMI26O6933)  
    prezatide copper (UNII: 6BJQ43T1I9)  
    glycine (UNII: TE7660XO1C)  
    sorbitol (UNII: 506T60A25R)  
    ascorbic acid (UNII: PQ6CK8PD0R)  
    edetate disodium (UNII: 7FLD91C86K)  
    propyl gallate (UNII: 8D4SNN7V92)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68634-063-011 in 1 CARTON10/01/2014
    151 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2014
    Labeler - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health & Beauty Solutions, Inc. DBA872684803MANUFACTURE(68634-063) , PACK(68634-063) , LABEL(68634-063) , ANALYSIS(68634-063)