Drug Facts

Active Ingredients

Zinc Oxide 23%

Purpose

Sunscreen

Uses:

Helps prevent sunburn

Warnings:

For external use only.

Do not use

on damaged or broken skin.

Stop use and ask a doctor

if skin rash occurs.

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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

Directions:

Apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating, Immediately after towel drying, at least every 2 hours. Children under 6 months: 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-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients:

Camellia Sinensis Leaf Extract (Organic Green Tea), Camellia Sinensis Leaf Extract (Organaic Black Tea), Cannabis Sativa Seed Oil (Organic Hemp Seed Oil), Cera Alba (Organic Beeswax), Coffea Arabica Seed Extract (Organic Coffee Bean), Helianthus Annuus Seed Oil (Organic Sunflower Oil), Iron Oxides, Mangifera Indica Seed Butter (Natural Mango Butter), Rosmarinus Officinalis Leaf Oil (Natural Rosemary, Theobroma Cacao Seed Butter (Organic Cocoa Butter), Tocopherol
*Certified Organic

Other Information:

Protect this product from excessive heat and direct sun.

Package Labeling:

Label

RAW ELEMENTS ECO FORMULA SPF30 SAMPLE PACKS
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70680-308
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	230 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WHITE WAX (UNII: 7G1J5DA97F)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
ROSEMARY OIL (UNII: 8LGU7VM393)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70680-308-00	4 g in 1 PACKET; Type 0: Not a Combination Product	08/16/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	08/16/2019

Labeler - Raw Elements LLC (023973143)

Raw Elements Eco Lotion Formula SPF30+ Sample Packs