Drug Facts

Active Ingredients

Zinc oxide 22.75%

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 helps 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

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:

• limit time in the sun especially from 10 am - 2 pm • wear long-sleeve shirts, pants, hats, and sunglasses

• children under 6 months: Ask a doctor

Inactive ingredients

Camellia Sinensis Leaf Extract (Organic Green Tea), Camellia Sinensis Leaf Extract (Organic Black Tea), Cannabis Sativa Seed Oil (Organic Hemp Seed Oil), Cera Alba (Organic Beeswax), Coffea Arabica Seed Extract (Oranic Coffee Bean), Euphorbia Cerifera Cera (Natural Candelilla Wax), Helianthus Annuus Seed Oil (Organic Sunflower Oil), Iron Oxide, Mangifera Indica Seed Butter (Natural Mango Butter), Rosmarinus Officinalis Leaf Oil (Natural Rosemary), Theobroma Cacao Seed Butter (Organic Cocoa Butter), Tocopherol

Other information

• pretect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-442-6676

Package Labeling:

RAW ELEMENTS LIP RESCUE 30 BROAD SPECTRUM SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70680-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	227.5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
WHITE WAX (UNII: 7G1J5DA97F)
SUNFLOWER OIL (UNII: 3W1JG795YI)
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:70680-301-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	05/03/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/03/2016

Labeler - Raw Elements LLC (023973143)

Raw Elements Lip Rescue 30 Broad Spectrum SPF 30