MINERAL FACE MATTE TINT UNSCENTED SPF 30 BROAD SPECTRUM- sunscreen lotion

Mineral Face Matte Tint Unscented by

Drug Labeling and Warnings

Mineral Face Matte Tint Unscented by is a Otc medication manufactured, distributed, or labeled by Bell International Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Titanium Dioxide 3.2%, Zinc Oxide 1.8%

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 doctor if skin rash occurs

Keep out of reach of children. If produt is swallowed, get medical help or contact a Poison Control Center right away

Directions

apply liberally 15 minutes before sun exposure

reapply:

• after 40 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 sunb protection measures including:

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

Children under 6 months: Ask a doctor

Inactive ingredients

Aluminum Hydroxide, Butyrospermum Parkii (Shea Butter), Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Dimethicone Crosspolymer, Glycerin, Hydrogen Dimethicone, Iron Oxides, Isopropyl Myristate, Isopropyl Titanium Triisostearate, Linum Usitatissimum (Linseed) Seed Oil, Mica, Oenothera Biennis (Evening Primrose) Oil, Plankton Extract, Polyamide-5, Polysilicone-11, Propylene Carbonate, Rosa Canina Fruit Oil, Silica Silylate, Stearalkonium Hectorite, Synthetic Wax

Other information

protect this prodcut from excessive heat and direct sun

PDP

INGREDIENTS AND APPEARANCE

MINERAL FACE MATTE TINT UNSCENTED  SPF 30 BROAD SPECTRUM
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
SHEA BUTTER (UNII: K49155WL9Y)
ROSA CANINA SEED (UNII: 4503R1M9UT)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
CUCUMBER (UNII: YY7C30VXJT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
LINSEED OIL (UNII: 84XB4DV00W)
PARAFFIN (UNII: I9O0E3H2ZE)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-126-11	50 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2012

Labeler - Bell International Laboratories, Inc. (967781555)