Label: BEAUTY 360 ACCELERATED WRINKLE REPAIR MOISTURIZER- homosalate, octisalate, avobenzone, octocrylene liquid

  • NDC Code(s): 68634-054-01
  • 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 March 8, 2016

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

  • SPL UNCLASSIFIED SECTION

    HBS Code (Labeler): FP12101-30.1

    Distributor: CVS Pharmacy, Inc.

    Human OTC Drug

    Active Ingredients: Avobenzone 2.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 2.0%

    CARTON TEXT

    ________________________________________________________

    beauty 360™

    ACCELERATED WRINKLE REPAIR MOISTURIZER

    MEASURABLE RESULTS

    Rapid retinol SR

    Formulated without parabens

    UVA/UVB protection

    BROAD SPECTRUM SPF 30 SUNSCREEN

    SPF 30

    COMPARE TO NEUTROGENA® RAPID WRINKLE REPAIR MOISTURIZER*

    CVS pharmacy®

    1 FL (29 mL)

    beauty 360™

    Drug Facts

  • Active ingredients

    Avobenzone 2.0%

    Homosalate 4.0%

    Octisalate 4.0%

    Octocrylene 2.0%

  • Purpose

    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

    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

    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, Styrene/Acrylates Copolymer, Glycerin, Dimethicone, Isononyl Isononanoate, Trisiloxane, Steareth-21, Pentylene Glycol, Cetyl Alcohol, Phenoxyethanol, Silica, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Steareth-2, PEG-100 Stearate, Glyceryl Stearate, Polysorbate 20, Dimethicone/Vinyl Dimethicone Crosspolymer, Chlorphenesin, Retinol, Xanthan Gum, BHT, Ethylhexylglycerin, Disodium EDTA, Nylon-12, Sodium Hydroxide, Hydrolyzed Myrtus Communis Leaf Extract, Stearyl Alcohol, Tocopheryl Acetate, Sodium Hyaluronate, Propyl Gallate, Ascorbic Acid, Fragrance

    beauty 360™

    Beauty 360 offers a collection of superior quality products to suit your individual daily needs from head to toe.

    Beauty 360: reinventing beauty.

    Accelerated Wrinkle Repair Moisturizer with Broad Spectrum SPF 30 Sunscreen works quickly for measurable results.

    Retinol is clinically proven to help:

    Reduce the appearance of age spots and discolorations

    Even out skin tone

    Minimize the visible signs of aging, including fine lines and wrinkles

    *This product is not manufactured or distributed by Johnson & Johnson Consumer Companies Inc., owner of the registered trademark Neutrogena®.

    This product is covered by U.S. Patents 6,500,411 and 6,716,418

    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 foreign components

    V-13649

    CVS® Quality

    Money Back Guarantee

    What is retinol?

    Retinol is a form of Vitamin A that naturally absorbs into your skin. It helps your skin achieve a smoother, more youthful appearance.

    Rapid retinol SR

    Combines a potent level of pure retinol with plant-based Phyto-Complex to help skin look and feel younger.

    It is a unique combination of the following ingredients:

    Retinol SR

    Sustained Release technology contains wrinkle-smoothing retinol and helps reduce the appearance of age spots

    Hyaluronic Acid

    Hydrates skin to provide line-plumping moisture for a more rejuvenated appearance

    Phyto-Complex

    Helps improve skin tone and reduces the appearance of wrinkles

    Warnings:

    You may experience mild tingling and/or redness. This is a sign that the product is working. If discomfort occurs, reduce use to every other day. Discontinue use if irritation persists. Protect this product from excessive heat and direct sun.

    Caution: For external use only. Avoid getting into eyes. If product gets into eyes, rinse thoroughly with water. Keep out of reach of children.

    M050891

    FP121

    ________________________________________________________

    end of text

    160225

    AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care

    301 Laser Lane Lafayette, LA 70507 | www.amcolhpc.com

    lauren.haase@amcol.com

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Carton Label

    beauty 360™

    ACCELERATED WRINKLE REPAIR
    MOISTURIZER

    MEASURABLE RESULTS

    Rapid retinol SR

    Formulated without parabens

    UVA/UVB protection

    BROAD SPECTRUM SPF 30 SUNSCREEN

    SPF 30

    COMPARE TO NEUTROGENA® RAPID WRINKLE REPAIR MOISTURIZER*

    CVS pharmacy®

    1 FL (29 mL)

    Principal Display Panel - Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel - Bottle Label

    beauty 360™

    ACCELERATED WRINKLE REPAIR

    MOISTURIZER

    MEASURABLE RESULTS

    Rapid retinol SR

    Formulated without parabens

    BROAD SPECTRUM SPF 30 SUNSCREEN

    SPF 30

    1 FL (29 mL)

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    BEAUTY 360 ACCELERATED WRINKLE REPAIR MOISTURIZER 
    homosalate, octisalate, avobenzone, octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68634-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    homosalate (UNII: V06SV4M95S) (homosalate - UNII:V06SV4M95S) homosalate40 g  in 2 mL
    octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) octisalate40 g  in 2 mL
    avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone20 g  in 2 mL
    octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene20 g  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    styrene/acrylamide copolymer (mw 500000) (UNII: 5Z4DPO246A)  
    glycerin (UNII: PDC6A3C0OX)  
    dimethicone (UNII: 92RU3N3Y1O)  
    isononyl Isononanoate (UNII: S4V5BS6GCX)  
    trisiloxane (UNII: 9G1ZW13R0G)  
    steareth-21 (UNII: 53J3F32P58)  
    pentylene glycol (UNII: 50C1307PZG)  
    cetyl alcohol (UNII: 936JST6JCN)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)  
    carbomer copolymer type b (allyl pentaerythritol crosslinked) (UNII: 809Y72KV36)  
    steareth-2 (UNII: V56DFE46J5)  
    peg-100 stearate (UNII: YD01N1999R)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    dimethicone/vinyl dimethicone crosspolymer (soft particle) (UNII: 9E4CO0W6C5)  
    chlorphenesin (UNII: I670DAL4SZ)  
    retinol (UNII: G2SH0XKK91)  
    xanthan gum (UNII: TTV12P4NEE)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    edetate disodium (UNII: 7FLD91C86K)  
    nylon-12 (UNII: 446U8J075B)  
    sodium hydroxide (UNII: 55X04QC32I)  
    myrtus communis leaf (UNII: U20N87188F)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    propyl Gallate (UNII: 8D4SNN7V92)  
    ascorbic acid (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68634-054-011 in 1 CARTON04/01/2016
    130 mL in 1 BOTTLE; 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 - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health & Beauty Solutions, Inc. DBA872684803MANUFACTURE(68634-054) , PACK(68634-054) , LABEL(68634-054) , ANALYSIS(68634-054)