Label: ANTI-WRINKLE AND FIRMING BROAD SPECTRUM SPF18 SUNSCREEN- avobenzone, octisalate, octocrylene cream

  • 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 May 21, 2014

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  • Active ingredient

    Avobenzone, 2.0%
    Oclisalate, 5.0%
    Octocrylene, 5.0%

  • 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

    •
    Apply liberally 15 minutes before sun exposure
    •
    Reapply at least every 2 hours
    •
    Use 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: ask a doctor
  • Other Information

    •
    protect the product in this container from excessive heat and direct sun
  • Inactive Ingredients

    water, cyclopentasiloxane, glycerin, titanium dioxide, glyceryl stearate, PEG-100 stearate, beeswax, myristyl myristate, stearic acid, palmitic acid, polyglyceryl-10 pentastearate, behenyl alcohol, sodium steroyl lactylate, tocopheryl acetate (vitamin E), butylene glycol, carbomer, polysorbate 20, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, cetyl alcohol, stearyl alcohol, hydrolyzed soy protein, dipalmitoyl hydroxyproline, fragrance, triethanolamine, glycine soja (soybean) protein, xanthan gum, retinyl palmitate (vitamin A), phenoxyethanol, PEG-20 stearate, potassium sorbate, sodium benzoate, phenethyl alcohol, alcohol denat., chlorphenesin.

  • Package/Label Principal Display Panel - Carton Label

    CVS pharmacy™
    anti-wrinkle & firming day cream
    SPF 18
    Broad Spectrum SPF 18 Sunscreen
    Anti-wrinkle & firming moisturizer

    With retinol encapsulated provitamin A & tetrapepitide complex

    Smooths & firms skin

    Compare to L’Oreal® Revitalift® Anti-Wrinkle + Firming Day Cream*

    NET WT 1.7 OZ (49g)

    CVS/pharmacy™ Anti-Wrinkle & Firming Day Cream is uniquely formulated to smooth away the appearance of wrinkles and visibly improve the look of firmer skin. As we age, essential elastin fibers decrease and skin loses its firmness while wrinkles become more visible. The retinol encapsulated provitamin A and Tetrapeptide Complex help to reduce the appearance of wrinkles, and are specially formulated to provide sun protection and 24-hour moisturization. It’s non-greasy and is dermatologist tested for gentleness.

    Advanced Anti-Wrinkle Action
    Retinol encapsulated provitamin A helps skin renewal, reducing the look of fine lines and wrinkles. Results can be seen in just two weeks. This technology continuously acts to fight the signs of aging, minimizing the appearance of dark circles and puffiness.

    Innovative Firming
    The Tetrapeptide Complex has proven to show improved elastin fibers.† Skin’s surface appears more resilient and toned.

    Continuous Moisturization & Skin Protection
    24-hour moisturization helps soothe dry skin, and leaves skin looking radiant and revitalized. Broad spectrum UVA/UVB SPF 18 protects the skin and prevents skin damage by UV exposure.

    †In-vitro testing

    *This product is not manufactured or distributed by L’Oreal USA, Inc., owner of the registered trademarks L’Oreal® and Revitalift®.

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2014 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS

    Made in Israel V-31442

    CVS® Quality
    Money Back Guarantee

    Carton Label - Front
     
    Carton Label – Front
    Carton Label - Back
     
    Carton Label - Back
  • INGREDIENTS AND APPEARANCE
    ANTI-WRINKLE AND FIRMING BROAD SPECTRUM SPF18 SUNSCREEN 
    avobenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-378
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ROYAL JELLY (UNII: L497I37F0C)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SOY STEROL (UNII: PL360EPO9J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-20 STEARATE (UNII: NBX892EA57)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-378-121 in 1 CARTON
    148 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2014
    Labeler - CVS Pharmacy (062312574)
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