Label: SHOPKO ANTI-WRINKLE AND FIRMING MOISTURIZER DAY BROAD SPECTRUM SPF18- 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 April 8, 2014

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

  • Active ingredient

    Avobenzone, 2.0%
    Octisalate, 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.
    Children under 6 months of age: ask a doctor
    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:
    o
    limit time in the sun, especially from 10 a.m. - 2 p.m.
    o
    wear long-sleeved shirts, pants, hats and sunglasses
  • Other Information

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

    water, cyclohexasiloxane, 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, alcohol.

  • Package/Label Principal Display Panel - Carton Label

    SHOPKO®

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

    Anti-Wrinkle & Firming Moisturizer
    Day Cream / SPF 18 Broad Spectrum Sunscreen

    with Pro-Vitamin A, Teterapeptide Complex & Sepilift

    NET WT 1.7 OZ (48g)

    FIRMING & ANTI-WRINKLE: AN INNOVATIVE TECHNOLOGY
    Now experience the advanced actions against the signs of skin aging. New Anti-Wrinkle & Firming Day Cream Broad Spectrum SPF18 Sunscreen, with effective encapsulated Pro-Vitamin A, Tetrapeptide Complex and Sepilift will increase cell turnover, reduce wrinkles, firm the skin, and provide 24 hour moisturization.

    FORMULA ESSENTIALS

    UV SPF18 sunscreen
    Non-Comedogenic
    Dermatologist tested for gentleness
    Non-greasy

    *This product is not manufactured or distributed by L'Oreal®, owner of the registered trademark Revitalift®.

    Distributed by Shopko Stores
    Operating Co., LLC
    700 Pilgrim Way, Green Bay, WI 54307
    ©2014 Shopko Stores
    Operating Co., LLC
    www.shopko.com
    Manufactured in Israel
    37815 8C C1

    SHOPKO®
    Satisfaction Guaranteed

    By Refund or Exchange

    TRIPLE-ACTION TECHNOLOGY
    Advanced Anti-Wrinkle Action: Encapsulated Pro-Vitamin A and Sepilift will hasten skin renewal, reducing the amount of fine lines and wrinkles and their depth. Results can be seen in just two weeks. The new technology will continually act to help fight the signs of aging.

    Innovative Firming: Tetrapeptide Complex has proven to show renewed elastin and collagen fiber+. Skin's surface is remodeled, becoming more resilient and toned.

    Continuous Moisturization & Skin Protection: Provides 24 hour moisturization to soothe dry skin. Broad spectrum UVA/UVB SPF18 protects the skin and prevents skin damage by UV exposure.

    DIRECTIONS FOR USE: Every day, smooth gently onto face and neck until thoroughly absorbed. Use in the AM, alone or under makeup.

    Results: Skin's elasticity is improved, Visible reduction of wrinkles and skin looks smoother, Firmer skin

    Sepilift is a registered trademark owned by Seppic.

    + In-vitro testing

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    SHOPKO ANTI-WRINKLE AND FIRMING MOISTURIZER DAY BROAD SPECTRUM SPF18 
    avobenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-815
    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)  
    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)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    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)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-815-121 in 1 CARTON
    148 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2014
    Labeler - Shopko Stores Operating Co., LLC (023252638)