RAW ELEMENTS TINT 30 BROAD SPECTRUM SPF 30- zinc oxide stick

Raw Elements Tint 30 Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Raw Elements Tint 30 Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Raw Elements LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

RAW ELEMENTS TINT 30 BROAD SPECTRUM SPF 30 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70680-303
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70680-303-01	17 g in 1 TUBE; Type 0: Not a Combination Product	05/03/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/03/2016

Labeler - Raw Elements LLC (023973143)