CHEMICAL FREE SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion
Herban Roots LLC

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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Chemical Free Sunscreen Broad Spectrum SPF 30

Drug Facts

Active Ingredient

Zinc Oxide 13.45%

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 Sunflower 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:

Label

CHEMICAL FREE SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72209-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	134.5 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72209-000-00	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2018	03/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/01/2018	03/31/2019

Labeler - Herban Roots LLC (040718836)

Revised: 1/2019

Document Id: 7f2066b0-29f0-03e0-e053-2a91aa0a27ba

Set id: ea71264b-e992-4595-a996-0517b331c4e2

Version: 2

Effective Time: 20190110

Herban Roots LLC