Label: PREMIER VALUE ILLUMINATING DAILY MOISTURIZER- 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 December 10, 2012

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  • Active ingredient

    Avobenzone 3.0%

    Octisalate 5.0%

    Octocrylene 10.0%

  • Purpose

    Sunscreen

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    help 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.

  • 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

  • Inactive ingredients

    water, C12-15 alkyl benzoate, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, cetearyl alcohol, cetearyl glucoside, steareth-2, glycerin, steareth-21, dimethicone, cetearyl alcohol, phenyl trimethicone, polyacrylamide, C13-14 isoparaffin, laureth-7, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, panthenol (pro-vitamin B5), polymethyl methacrylate, lecithin, soy isoflavones, polysorbate 80, alcohol, benzyl alcohol, disodium EDTA, fragrance, benzalkonium chloride, BHT, triethanolamine

  • Package/Label Principal Display Panel

    Premier Value® Illuminating Daily Moisturizer
    Broad Spectrum SPF15 Sunscreen

    With an exclusive soy complex and light diffusers

    Clinically proven

    Evens out skin tone and texture

    4 FL OZ (120 mL)

    DISTRIBUTED BY:
    CHAIN DRUG CONSORTIUM
    3301 NW BOCA RATON BLVD
    SUITE 101, BOCA RATON,

    FL 33431
    MADE IN ISRAEL
    52326 C7 C1

    Premier Value Illuminating Daily Moisturizer Label

    Carton Label

     

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE ILLUMINATING DAILY MOISTURIZER 
    avobenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-523
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-523-261 in 1 CARTON
    1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/26/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Zohar Cosmetics (600076624)
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