Drug Facts

Active ingredient

Zinc Oxide 22%

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 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
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
Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

Caprylic/Capric Triglyceride, Grape (Vitis vinifera) Seed Oil, Silica, Shea (Butyrospermum parkii) Butter, Candelilla (Euphorbia cerifera) Wax, Beeswax, Fragrance (Parfum), Jojoba (Simmondsia chinensis) Seed Oil, Tocopherol, Safflower (Carthamus tinctorius) Seed Oil, Cucumber (Cucumis sativus) Fruit Extract, Glycerin, Water (Aqua), Tea (Camellia sinensis) Leaf Extract, Rosehip (Rosa canina) Fruit Oil

Package Labeling:

SUN NATURAL SUNSCREEN
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71086-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SHEA BUTTER (UNII: K49155WL9Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TEA LEAF (UNII: GH42T47V24)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GRAPE SEED OIL (UNII: 930MLC8XGG)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71086-000-01	1 in 1 BOX	11/16/2016
1		100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/16/2016

Labeler - Sun Naturals Inc (259934094)

Sun Natural Sunscreen