Label: ZRII NEW DAY BROAD SPECTRUM SPF-30- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 5, 2016

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  • ACTIVE INGREDIENTS

    Avobenzone  3.0%
    Homosalate  5.0%
    Octinoxate  5.0%
    Octocrylene  2.7%
    Oxybenzone  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

    Keep out of the reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Apply generously 15 minutes before sun exposure.
    • Children under 6 months of age: Ask a doctor
    • Reapply at least every 2 hours.
    • Use a 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:
    • 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

    Aqua, Carthamus Tinctorius (Safflower) Oleosomes, Glyceryl Stearate, Cetearyl Alcohol, Isodecyl Neopentanoate, Ceteareth-20, Cetyl Alcohol, Niacinamide, Caprylic/Capric Triglycerides (and) Sea Whip Extract, Diisopropyl Sebacate, Lauryl Lactate, Ascorbyl Glucoside, Tocopheryl Acetate, 7-Dehydrocholesterol, Sodium Polyacrylate, Sodium Citrate, Carbomer, Hexylene Glycol, Disodium Edta, Sodium Hydroxide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Citric Acid

  • QUESTIONS OR COMMENTS?

    Call toll free 1-866-349-9911

  • PRINCIPAL DISPLAY PANEL

    a1801V1_ZriiNew_SPF_CartonBox

  • INGREDIENTS AND APPEARANCE
    ZRII NEW DAY  BROAD SPECTRUM SPF-30
    avobenzone, homosalate, octinoxate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70528-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    CETEARETH-22 (UNII: 28VZG1E234)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70528-018-511 in 1 BOX07/05/2016
    1NDC:70528-018-1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/05/2016
    Labeler - ZRII, LLC (807457531)
    Establishment
    NameAddressID/FEIBusiness Operations
    Westwood Laboratories Inc.069926483manufacture(70528-018)
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