SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]

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  • SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]

SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC.]
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NDC 42421-926-11
Set ID e615176c-e829-4f5c-8d46-0fb405e9c1e2
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

    Titanium Dioxide 10.4%
    Zinc Oxide 4.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • If used as directed with other sun protections 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

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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: ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your risk of sun 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 10a.m. - 2p.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

    water, cyclopentasiloxane, C12-15 alkyl benzoate, caprylic/capric triglyceride, glycerin, cetyl PEG/PPG-10/1 dimethicone, cetyl dimethicone, trimethoxycaprylylsilane, phenyl trimethicone, phenoxyethanol, ethylhexylglycerin, sodium chloride, hydrogenated castor oil, microcrystaline wax, tocopheryl acetate (vitamin E), allantoin, panthenol (pro-vitamin B5), lecithin, soy isoflavones, polysorbate 80, hippophae rhamnoides oil, bisabolol, camomilla recutita (matricaria) flower extract, tilia vulgaris (linden blossom) flower extract, melissa officinalis (lemon balm) leaf extract, aspalanthus linearis (rooibos) leaf extract, sodium lactate, porphyra umbilicalis extract

  • Package/Label Principal Display Panel

    Safe Harbor™ Natural Suncare

    Free from chemical UV filters

    50 Mineral SPF Broad Spectrum Sunscreen

    Sensitive Lotion
    With Natural Anti-Aging Complex

    Moisturizing sunscreen lotion

    Anti-aging treatment
    rich in age-defying antioxidants

    4 Fl. Oz (118.3 mL)

    Distributed by: Emilia Personal Care.
    Manufactured in Israel.
    For more information visit: www.safeharborsuncare.com

    UVA, UVB
    With Certified Organic Ingredients
    Water Resistant
    Allergy Tested

    ZD926 2E T1

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-926
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10.4 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TRICAPRYLIN (UNII: 6P92858988)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    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)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42421-926-11118.3 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/05/2014
    Labeler - Emilia Personal Care Inc. (965445112)
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