Label: EARTHS BEST MINERAL SUNSCREEN BROAD SPECTRUM SPF30- zinc oxide, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 25, 2012

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  • 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