SUNZEE BROAD SPECTRUM SPF 40 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EMILIA COSMETICS LTD]

SUNZEE BROAD SPECTRUM SPF 40 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EMILIA COSMETICS LTD]
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NDC 43219-300-12, 43219-300-30, 43219-300-40
Set ID ffd6941e-ca63-499e-93ab-db327de793ca
Category HUMAN OTC DRUG LABEL
Packager Emilia Cosmetics Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients

    Titanium Dioxide, 7.1%

    Zinc Oxide, 3.5%

  • PURPOSE

    Purpose

    Sunscreen

    Sunscreen

  • INDICATIONS & USAGE

    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

    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 reach of children. If swallowed, get medical

    help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    •apply liberally 15 minutes before sun exposure

    •reapply at least every 2 hours

    •use water resistant sunscreen if swimming or sweating

    •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 sunglassses

  • STORAGE AND HANDLING

    Other information protect the product in this

    container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive Ingredients water, caprylic/capric

    triglyceride, sesamum indicum (sesame) seed oil,

    trimethoxycaprylylsilane, helianthus annuus (sunflower)

    seed oil, glycerin, coco-glucoside, coconut alcohol, ricinus

    communis (castor) oil, simmondsia chinensis (jojoba) seed

    oil, butyrospermum parkii (shea) butter, microcrystalline

    cellulose, cellulose gum, arachidyl alcohol, behenyl

    alcohol, arachidyl glucoside, phenoxyethanol,

    ethylhexylglycerin, xanthan gum, PEG-40 stearate,

    fragrance, allantoin, tocopheryl acetate (viatmin E),

    panthenol (pro-vitamin B5), lecithin, soy isoflavones,

    polysorbate 80, alcohol denat., hippophae rhamnoides

    oil, bisabolol

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNZEE   BROAD SPECTRUM SPF 40 SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.56 g  in 36 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.26 g  in 36 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    SESAME OIL (UNII: QX10HYY4QV)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43219-300-1212 in 1 DOSE PACK07/07/2017
    1NDC:43219-300-4036 mL in 1 CAPSULE; Type 0: Not a Combination Product
    2NDC:43219-300-3030 in 1 DOSE PACK07/07/2017
    2NDC:43219-300-4036 mL in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/06/2017
    Labeler - Emilia Cosmetics Ltd (600076624)

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