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balance-n-brighten

LAURA GELLER MAKE UP INC.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.
         

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



REGULAR

Net Wt. 0.32 oz./9 gbalance-n-brighten

balance-n-brighten

TITANIUM DIOXIDE POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:51389-103
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 10 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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 9 in 1 CONTAINER
2 NDC:51389-103-01 1 in 1 KIT

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-11-01


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