ZRII NEW DAY BROAD SPECTRUM SPF-30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [ZRII, LLC]

ZRII NEW DAY BROAD SPECTRUM SPF-30 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [ZRII, LLC]
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NDC 70528-018-11, 70528-018-51
Set ID 2ab19062-25ab-46a1-9f36-d02dd1c66f38
Category HUMAN OTC DRUG LABEL
Packager ZRII, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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