OTC Medication Information: Earths Best Mineral Sunscreen Broad Spectrum SPF30

EARTHS BEST MINERAL SUNSCREEN BROAD SPECTRUM SPF30 — zinc oxide and 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.


Zinc Oxide 14.5%

Titanium Dioxide 2.0%

Sunscreen

  • 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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0212
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 14.5 g in 100 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.0 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERIN
ALOE VERA LEAF
SUNFLOWER OIL
DIMETHICONE
JOJOBA OIL
ETHYLHEXYL PALMITATE
SORBITAN SESQUIOLEATE
SHEA BUTTER
GRAPE SEED OIL
CALENDULA OFFICINALIS FLOWER
CHAMOMILE
MAGNESIUM SULFATE
SILICON DIOXIDE
SODIUM CHLORIDE
.ALPHA.-TOCOPHEROL ACETATE
BENZYL ALCOHOL
PHENOXYETHANOL
POLYHYDROXYSTEARIC ACID (2300 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-0212-4 113 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/19/2011
Labeler — The Hain Celestial Group, Inc. (858894996)
Establishment
Name Address ID/FEI Operations
The Hain Celestial Group, Inc. 858894996 manufacture

Revised: 05/2012 The Hain Celestial Group, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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