BE NATURAL ORGANICS BROAD SPECTRUM NUDE TINT SPF 30- zinc oxide cream

Be Natural Organics Broad Spectrum Nude Tint SPF 30 by

Drug Labeling and Warnings

Be Natural Organics Broad Spectrum Nude Tint SPF 30 by is a Otc medication manufactured, distributed, or labeled by Kabana Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide USP** 25%

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

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.

Warnings

For external use only if used as directed with other sun protection measures

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply:
• after 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 AM – 2 PM.
• wear long-sleeved shirts, pants, hats and sunglasses.
• Children under 6 months. Ask a doctor.

Inactive Ingredients

Eldorado Springs Artesian water ( aqua), extra virgin olive oil* ( Oleo europaea fruit oil), jojoba oil* ( Simmondsia chinensis seed oil), vegetable glycerin# ( glycerin), shea butter* ( Butyrospermum parkii seed oil), vegetable emulsifying wax NF# ( cetearyl alcohol and polysorbate 60), vegetable vitamin e# ( tocopherol), iron oxides ( iron oxides).

*Certified Organic by USDA/NOP #Non-GMO **non-nano, uncoated, French Process zinc oxide

Other Information

• protect this product from excessive heat and direct sun

Questions or comments?

Call Be Natural Organics at 248 851 8347 or visit www.benaturalorganics.com

Manufactured for Be Natural Organics, West Bloomfield, MI 48323

INGREDIENTS AND APPEARANCE

BE NATURAL ORGANICS BROAD SPECTRUM NUDE TINT SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73369-1002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)	0.08 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M)	1.125 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	3.75 g  in 100 g
FERRIC OXIDE RED (UNII: 1K09F3G675)	0.15 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	1.125 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E)	24.65 g  in 100 g
WATER (UNII: 059QF0KO0R)	35 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	1.93 g  in 100 g
JOJOBA OIL (UNII: 724GKU717M)	3.75 g  in 100 g
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)	0.27 g  in 100 g
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	1.38 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73369-1002-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2014
2	NDC: 73369-1002-2	115 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/15/2014

Labeler - Kabana Skin Care (080237112)