Label: PREMIER VALUE DAILY FACIAL MOISTURIZER- avobenzone, 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 7, 2012

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

  • Active ingredient

    Avobenzone 3.0%

    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, diisopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, disodium EDTA

  • Package/Label Principal Display Panel

    Premier Value® Daily Facial Moisturizer

    Broad Spectrum SPF15 Sunscreen

    • non-greasy and lightweight
    • protects from UVA and UVB rays
    • non-comedogenic (won't clog pores)
    • fragrance-free and paba-free
    • dermatologist tested

    4 FL OZ (118 mL)

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

    FL 33431
    MADE IN ISRAEL
    2T326 C7 C1

    Daily Facial Moisturizer Label

    Daily Facial Moisturizer Label

     

  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE DAILY FACIAL MOISTURIZER 
    avobenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-213
    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) OCTOCRYLENE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW) (UNII: 99Q3C7L77T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-213-261 in 1 CARTON
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/29/2012
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Zohar Cosmetics (600076624)