EARTHS BEST MINERAL SUNSCREEN BROAD SPECTRUM SPF30 (ZINC OXIDE, TITANIUM DIOXIDE ) LOTION [THE HAIN CELESTIAL GROUP, INC.]

EARTHS BEST MINERAL SUNSCREEN BROAD SPECTRUM SPF30 (ZINC OXIDE, TITANIUM DIOXIDE ) LOTION [THE HAIN CELESTIAL GROUP, INC.]
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NDC 61995-0212-4
Set ID 98b531ba-777e-4714-9c5e-8c628493add4
Category HUMAN OTC DRUG LABEL
Packager The Hain Celestial Group, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT


    Zinc Oxide  14.5%

    Titanium Dioxide  2.0%



  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    • Helps prevent sunburns
    • If used as described with other sun protection measures, 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 skin 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

    Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months, ask a doctor . Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease risk, regularly use a sunscreen  with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in the sun, especially from 10am to 2pm and wear long-sleeved shirts, pants, hats and sunglasses.

  • INACTIVE INGREDIENT

     Aqua (Water), Aloe Barbadensis Leaf Juice (1), Caprylic/Capric Triglycerides, Dimethicone, Ethylhexyl Palmitate,  Sorbitan Sesquioleate, Glycerin, Butyrospermum Parkii (Shea Butter), Helianthus Annuus (Sunflower) Seed Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Polyglyceryl-3 Ricinoleate, Vitis Vinifera (Grape) Seed) Oil, Calendula Officinalis Flower Extract (1),Chamomilla Recutita (Matricaria ) Flower Extract (1), Magnesium Sulfate, Silica, Sodium Chloride,Tocopheryl Acetate, Benzyl Alcohol, Phenoxyethanol, Polyhydroxystearic Acid.


    (1) Certified Organic Ingredients

  • QUESTIONS

    Questions? Call (877) 527-6801or visit www.earthsbest.com

  • PRINCIPAL DISPLAY PANEL

    image of bottle front label
                
    image of bottle back label
  • INGREDIENTS AND APPEARANCE
    EARTHS BEST MINERAL SUNSCREEN BROAD SPECTRUM SPF30 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0212-4113 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/19/2011
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture

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