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

SAFE HARBOR NATURAL SUNCARE BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [EMILIA PERSONAL CARE INC]
PDF | XML

NDC 42421-575-15
Set ID ae98d652-b2c8-4c81-a126-e054d6b8eb88
Category HUMAN OTC DRUG LABEL
Packager Emilia Personal Care Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Titanium Dioxide  7.6%

    Zinc Oxide  4.0%

  • PURPOSE

    Purpose

    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, cetearyl alcohol,

    cetearyl glucoside, simmondsia chinensis

    (jojaba) seed oil, glyceryl stearate,

    butyrosperum parkii (shea) butter, potassium

    cetyl phosphate, phenoxyethanol, ethylhexylglycerin,

    xanthan gum, PEG-40 stearate, trimethoxycaprylsilane, allantoin,

    tocopherol acetate (vitamin E), panthenol (pro-vitamin B5),

    bisabolol, hippophae rhamnoides oil, avena sativa (oat) kernel extract,

    echinacea purpurea root extract, chamomilla recutita (matricaria) flower extract,

    tilia vulgaris flower extract, melissa officinalis leaf extract,

    aspalathus linearis leaf extract

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SAFE HARBOR NATURAL SUNCARE  BROAD SPECTRUM
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.4 g  in 124 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.96 g  in 124 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SESAME OIL (UNII: QX10HYY4QV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    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)  
    OAT (UNII: Z6J799EAJK)  
    ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
    MATRICARIA RECUTITA ROOT (UNII: BTG5H50X7F)  
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42421-575-15124 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/15/2015
    Labeler - Emilia Personal Care Inc (965445112)

Related Drugs