BALANCE-N-BRIGHTEN REGULAR - titanium dioxide powder
LAURA GELLER MAKE UP INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Titanium Dioxide 10%

Purpose

Sunscreen

Use

Helps prevent sunburn.
Higher SPF gives more sunburn protection.
Provides moderate protection against sunburn.

Warnings

For external use only.

When using this product

Keep out of eyes.
Rinse with water to remove.

Stop use and ask a doctor if

Rash or irritation develops and lasts. You may report side effect to FDA at 1-800-FDA-1088.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply evenly before sun exposure as needed.
Children under 6 months of age: ask a doctor.

Other Information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

Talc, Mica, Dimethicone, Titanium Dioxide (CI 77891), Isopropyl Palmitate, Iron Oxides (CI 77492), Polysorbate 20, Iron Oxides (CI 77491), Magnesium Aluminum Silicate, Iron Oxides (CI77499), Phenoxyethanol, Lauroyl Lysine, Sodium Dehydroacetate, Manganese Violet (CI 77742), Simmondsia Chinensis(Jojoba) Seed Oil, Ethylhexyl Methoxycinnamate, Tocopheryl Acetate, Retinyl Palmitate, Chromium Oxide Greens (CI 77288), BHT, Cintella Asiatica Extract, Camellia Sinensis Leaf Extract

Questions?

Call Laura Geller Make-up, Inc., 1(800) MAKE UP4

Principal Display Panel

LAURA GELLER

BEAUTY INGENUITY

balance-n-brighten
SPF 15

Baked Color Correcting
Foundation

with Retractable Baked Powder Brush

REGULAR

Net Wt. 0.32 oz./9 g Balance-n-Brighten SPF 15 Regular - Carton

BALANCE-N-BRIGHTEN REGULAR
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51389-103
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	10 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC
MICA
DIMETHICONE
TITANIUM DIOXIDE
ISOPROPYL PALMITATE
FERRIC OXIDE YELLOW
POLYSORBATE 20
FERRIC OXIDE RED
MAGNESIUM ALUMINUM SILICATE
FERROSOFERRIC OXIDE
PHENOXYETHANOL
LAUROYL LYSINE
SODIUM DEHYDROACETATE
JOJOBA OIL
OCTINOXATE
ALPHA-TOCOPHEROL ACETATE
VITAMIN A PALMITATE
CHROMIC OXIDE
BUTYLATED HYDROXYTOLUENE
CENTELLA ASIATICA
GREEN TEA LEAF

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:51389-103-01	1 CONTAINER ( CONTAINER) in 1 KIT	contains a CONTAINER
1		9 g in 1 CONTAINER	This package is contained within the KIT (51389-103-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2011

Labeler - LAURA GELLER MAKE UP INC. (199474524)

Establishment
Name	Address	ID/FEI	Operations
CHROMAVIS SPA		338561621	manufacture

Revised: 11/2011 LAURA GELLER MAKE UP INC.