DR. MERCOLA SUNSCREEN BROAD SPECTRUM SPF-30 - zinc oxide cream
Pure Source 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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DR. MERCOLA Sunscreen Broad Spectrum SPF-30

Active Ingredient

Zinc Oxide (20%)

Purpose

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, Aloe Barbadensis Leaf Juice, Helanthus Annuus (Sunflower) Seed Oil, Lecithin, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Sorbitan Olivate, Glycerin, Simmonds Chinensia (Jojoba) Seed Oil, Butyrospermum ParkII (Shea) Butter, Camellia Sinensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Glucurolactone, Potassium Sorbate, Xanthan Gum, Punica Granalum Fruit Extract, Tocopherol, Rubus Idaeus (Raspberry) Seed Oil, Astaxanthain Eucalyptus Globulus Leaf Oil.

DR. MERCOLA Sunscreen Broad Spectrum SPF-30

SPF 30

DR. MERCOLA SUNSCREEN BROAD SPECTRUM SPF-30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:65121-883
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	200 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
ALOE VERA LEAF
SUNFLOWER OIL
CETOSTEARYL ALCOHOL
CETEARYL GLUCOSIDE
CETEARYL OLIVATE
SORBITAN OLIVATE
GLYCERIN
JOJOBA OIL
SHEA BUTTER
GREEN TEA LEAF
COCONUT OIL
GLUCUROLACTONE
POTASSIUM SORBATE
XANTHAN GUM
POMEGRANATE
TOCOPHEROL
RASPBERRY SEED OIL
ASTAXANTHIN
EUCALYPTUS OIL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65121-883-30	236 mL in 1 BOTTLE

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

Labeler - Pure Source Inc (969241041)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source Inc		969241041	manufacture(65121-883)

Revised: 4/2014

Document Id: 8e2f7509-3bf1-44ee-8b5e-1724d4cd6ed6

Set id: c06070ea-dd7c-4e38-934d-4417f8c43a17

Version: 1

Effective Time: 20140428

Pure Source Inc