EARTHS BEST MINERAL SUNSCREEN BROAD SPECTRUM SPF30 - zinc oxide, titanium dioxide  lotion 
The Hain Celestial Group, Inc.

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.

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Drug Facts


Zinc Oxide  14.5%

Titanium Dioxide  2.0%



Sunscreen

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

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.

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

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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

Revised: 5/2012
Document Id: 13623c75-93cd-4ab3-a056-5db8830784c4
Set id: 98b531ba-777e-4714-9c5e-8c628493add4
Version: 1
Effective Time: 20120525
 
The Hain Celestial Group, Inc.