PUBLIC GOODS (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EMILIA COSMETICS LTD]

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PUBLIC GOODS (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [EMILIA COSMETICS LTD]
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NDC 43219-008-03, 43219-008-50
Set ID fde1e41f-142b-49b2-9eae-bdda5cd098f2
Category HUMAN OTC DRUG LABEL
Packager Emilia Cosmetics Ltd
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active ingredients

    Titanium Dioxide, 7.6%

    Zinc Oxide, 4.0%

  • 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, hatsand sunglasses. 

  • STORAGE AND HANDLING

    Other information •protect product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients water, caprylic/capric triglyceride, sesamum

    indicum (sesame) seed oil, helianthus annuus (sunflower) seed oil,

    glycerin, coco-glucoside, coconut alcohol, ricinus communis (castor)

    oil, simmondsia chinensis (jojoba) seed oil, butyrosperum parkii

    (shea) butter, microcrystalline cellulose, cellulose gum, arachidyl

    alcohol, behenyl alcohol, arachidyl glucoside, phenoxyethanol,

    ethylhexylglycerin, xantham gum, PEG-40 stearate,

    trimethoxycarpylylsilane, allantoin,tocopheryl acetate (vitamin E),

    panthenol (pro-vitamin B5), bisabolol, hippophae rhammnioides oil,

    echinacea purpurot extract, avena sativa (oat) extract, chamomilla

    recutita (matricaria) flower extract, tilia vulgaris flower extract,

    melissa officinalis leaf extract, aspalathus linearis leaf extract

  • QUESTIONS

    Questions or comments?  (855) 506-6742

  • label

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  • INGREDIENTS AND APPEARANCE
    PUBLIC GOODS 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE18 g  in 236 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.5 g  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SESAME OIL (UNII: QX10HYY4QV)  
    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 ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
    OAT BRAN (UNII: KQX236OK4U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
    MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43219-008-50236 mL in 1 TUBE; Type 0: Not a Combination Product02/04/2018
    2NDC:43219-008-03124 mL in 1 TUBE; Type 0: Not a Combination Product06/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/04/2018
    Labeler - Emilia Cosmetics Ltd (600076624)
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