DR. MERCOLA SUNSCREEN SPF-50- titanium dioxide, zinc oxide cream

DR. MERCOLA Sunscreen SPF-50 by

Drug Labeling and Warnings

DR. MERCOLA Sunscreen SPF-50 by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR. MERCOLA Sunscreen SPF-50

ACTIVE INGREDIENT

Titanium Dioxide (6.0%)
Zinc Oxide (22.5%)

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), sunscreen 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 rash occurs

Keep out of reach of children.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Children under 6 months of age: 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-sleeve shirts, pants, hats, and sunglasses
• Re-apply:
• • After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
    

Other Information

• Protect the product in this container from excessive heat and direct sun
  

Inactive Ingredients

Aqua, Helanthus Annuus (Sunflower) Seed Oil, Lecithin, Glycerin, Cocos Nucifera (Coconut) Oil, Butyrospermum ParkII (Shea) Butter, Camellia Sinensis Leaf Extract, Xanthan Gum, Simmonds Chinensia (Jojoba) Seed Oil, Tocopherol, Glucurolactone, Eucalyptus Globulus Leaf Oil.

DR. MERCOLA Sunscreen SPF-50

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INGREDIENTS AND APPEARANCE

DR. MERCOLA SUNSCREEN SPF-50 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-886
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	225 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
XANTHAN GUM (UNII: TTV12P4NEE)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-886-50	160 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/28/2014

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-886)