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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

Mica,Talc, Dimethicone, Nylon-12, Titanium Dioxide(CI 77891), Isopropyl Palmitate, Polysorbate 20, Iron Oxide (CI 77492), Iron Oxide (CI 77491), Magnesium Aluminum Silicate, Phenoxyethanol, Iron Oxide (CI 77499), Sodium Dehydroacetate, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexyl Methoxycinnamate, Retinyl Palmitate, Tocopheryl Acetate, BHT, Chromium Oxide Greens (CI 77288), Lauroyl Lysine, Camellia Sinensis Leaf Extract, Centella Asiatica Extract

Questions?

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

Principal Display Panel

LAURA GELLER

BEAUTY INGENUITY

balance-n-brighten
SPF 15



with Retractable Baked Powder Brush

FAIR

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:51389-101
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
MICA
talc
DIMETHICONE
titanium dioxide
ISOPROPYL PALMITATE
POLYSORBATE 20
FERRIC OXIDE YELLOW
ferric oxide red
magnesium aluminum silicate
PHENOXYETHANOL
FERROSOFERRIC OXIDE
SODIUM DEHYDROACETATE
Jojoba Oil
OCTINOXATE
VITAMIN A PALMITATE
ALPHA-TOCOPHEROL ACETATE
BUTYLATED HYDROXYTOLUENE
CHROMIC OXIDE
LAUROYL LYSINE
GREEN TEA LEAF
CENTELLA ASIATICA

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 9 in 1 CONTAINER
2 NDC:51389-101-01 1 in 1 KIT

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-11-13


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