SAFE HARBOR NATURAL SUNCARE NATURAL FACE AND NECK BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]

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SAFE HARBOR NATURAL SUNCARE NATURAL FACE AND NECK BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]
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NDC 42421-076-15
Set ID df6b976c-c8d4-48e3-8d11-489c408e10f6
Category HUMAN OTC DRUG LABEL
Packager Emilia Personal Care Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • 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  -After 80 minutes of swimming or sweating

    -immediately after towel drying  -At least every 2 hours; Children

    under 6 months: 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 sunglasses.

  • 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, 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, trimethoxycaprylylsilane,

     fragrance, allantoin, tocopheryl acetate

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

     isflavones, polysorbate 80, hippophae rhamnoides

     oil, bisabolol, chamomilla recutita (matricaria)flower

     extract, tilia vulgaris _ower extract, Melissa

     officinalis leaf extract, aspalathus linearis leaf

     extract, sodium lactate, porphyra umbilicalis extract

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SAFE HARBOR NATURAL SUNCARE  NATURAL FACE AND NECK BROAD SPECTRUM
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.8 g  in 124 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.34 g  in 124 g
    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 ACID (UNII: 40U37V505D)  
    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)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG-40 SOY STEROL (UNII: 58L481H732)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CHAMOMILE (UNII: FGL3685T2X)  
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42421-076-15124 g in 1 TUBE; Type 0: Not a Combination Product12/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/30/2016
    Labeler - Emilia Personal Care Inc (965445112)
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