CHEMICAL FREE SUNSCREEN- zinc oxide lotion

Chemical Free Sunscreen by

Drug Labeling and Warnings

Chemical Free Sunscreen by is a Otc medication manufactured, distributed, or labeled by Herban Roots, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Drug Facts

​Active Ingredient

Zinc Oxide 14.57%

​Purpose

Sunscreen

​Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), 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.
• Reapply:
• after 40 minutes of swimming or sweating.
•  immediately after towel drying.
•  at least every 2 hours.
• 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 of 15 or higher and other sun protection measures including:
• limited time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: ask a doctor.

​Inactive Ingredients:

Organic High Oleic Sunflower Oil, Organic Coconut Oil, Beeswax, Organic Shea Butter, Tocopherols, Fragrance (All Natural), Carrot Seed Oil.

​Other Information

• Protect this product from excessive heat and direct sun.

Package Labeling

INGREDIENTS AND APPEARANCE

CHEMICAL FREE SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72209-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	145.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARROT SEED OIL (UNII: 595AO13F11)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72209-001-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2019

Labeler - Herban Roots, LLC (040718836)