Label: ADVANCED FIRMING AND ANTI WRINKLE- avobenzone, octisalate and 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 January 10, 2014

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  • 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
    •
    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 sun
  • Inactive ingredients

    water, cyclopentasiloxane, cyclohexasiloxane, glycerin, titanium dioxide, alumina, simethicone, squalane, glyceryl stearate, PEG-100 stearate, simmondsia chinensia (jojoba) seed oil, beeswax, myristyl myristate, stearic acid, polyglyceryl-10 pentastearate, bhenyl alcohol, sodium steroyl lactylate, tocopheryl acetate (vitamin E), dipalmitoyl hydroxyproline, butylene glycol, carbomer, polysorbate 20, palmitoyl oiligopeptide, palmitoyl tetrapeptide-7, lecithin, soy isoflavones, polysorbate 80, alcohol, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, cetearyl alcohol, steareth-2, phenoxyethanol, polyacrylate-13, polyisobutene, glycine soja (soybean) protein, fragrance, triethanolamine, xanthan gum, retinyl palmitate, allantoin

  • Package/Label Principal Display Panel

    Rite Aid RENEWAL™
    advanced anti-wrinkle & firming DAY CREAM Broad Spectrum SPF18 Sunscreen

    MOISTURIZE

    With Encapsulated Pro-Vitamin A
    For Face & Neck

    NET WT 1.7 OZ (48 g)

    *Compare to L'Oreal® Advanced Revitalift® Complete Day Cream SPF18 Ingredients

    DISTRIBUTED BY:
    RITE AID
    30 HUNTER LANE
    CAMP HILL, PA 17011

    Manufactured in Israel
    37815 83 C2

    Principal display panel - carton label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    ADVANCED FIRMING AND ANTI WRINKLE 
    avobenzone, octisalate and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-9785
    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 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-9785-21 in 1 CARTON
    148 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/17/2012
    Labeler - Rite Aid Corporation (014578892)
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