MULTI EFFECT DAY CREAM SPF 25 (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE) CREAM [SANO INTERNATIONAL LTD.]

MULTI EFFECT DAY CREAM SPF 25 (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, HOMOSALATE) CREAM [SANO INTERNATIONAL LTD.]
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NDC 69435-1701-1
Set ID 50afd836-72c1-36be-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Sano International Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • PRINCIPAL DISPLAY PANEL

    Multi Effect Day Cream

    Octinoxate 7%

    Octocrylene 5%

    Octisalate 5%

    Avobenzone 3%

    Homosalate 2%

    Keep out of reach of children.

    Provides SPF 25 protection

    To Use: Smooth onto face.
    For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
    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 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-sleeve shirts, pants, hats, and sunglasses.

    Smooth on to face.

  • INGREDIENTS AND APPEARANCE
    MULTI EFFECT DAY CREAM SPF 25 
    octinoxate, octocrylene, octisalate, avobenzone, homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69435-1701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SEA SALT (UNII: 87GE52P74G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    WATER (UNII: 059QF0KO0R)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69435-1701-150 mL in 1 CONTAINER; Type 0: Not a Combination Product05/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/23/2016
    Labeler - Sano International Ltd. (514678390)
    Registrant - Peer Pharma Ltd. (514678390)
    Establishment
    NameAddressID/FEIBusiness Operations
    Peer Pharma Ltd.514678390manufacture(69435-1701)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sano International Ltd.600395487label(69435-1701)

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