Medication Guide App

bronze-n-brighten REGULAR

Dosage form: powder
Ingredients: TITANIUM DIOXIDE 10g in 100g
Labeler: LAURA GELLER MAKE UP INC.
NDC Code: 51389-106

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.

Drug Facts

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

Mica, Talc, Iron Oxide (CI 77491), Dimethicone, Nylon-12, Titanium Dioxide (CI 77891), Iron Oxide (CI 77492, CI 77499), Isopropyl Palmitate, Polysorbate 20, Magnesium Aluminum Silicate, Phenoxyethanol, Sodium Dehydroacetate, Simmondsia Chinensis (Jojoba) Seed Oil, Ethylhexyl Methoxycinnamate, Retinyl Palmitate, Tocopheryl Acetate, BHT, Lauroyl Lysine, Carmine (CI 75470), Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Tin Oxide. ‚óŹ Contains Carmine as a Color Additive

Questions?

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

Principal Display Panel

LAURA GELLER

BEAUTY INGENUITY

bronze-n-brighten
SPF 15

Baked Color Correcting
Bronzer

with Retractable Baked Powder Brush

REGULAR

Net Wt. 0.32 oz./9 g

BRONZE-N-BRIGHTEN  REGULAR
titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51389-106
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA 
TALC 
FERRIC OXIDE RED 
DIMETHICONE 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
ISOPROPYL PALMITATE 
POLYSORBATE 20 
MAGNESIUM ALUMINUM SILICATE 
PHENOXYETHANOL 
SODIUM DEHYDROACETATE 
JOJOBA OIL 
OCTINOXATE 
VITAMIN A PALMITATE 
ALPHA-TOCOPHEROL ACETATE 
BUTYLATED HYDROXYTOLUENE 
LAUROYL LYSINE 
COCHINEAL 
GREEN TEA LEAF 
CENTELLA ASIATICA 
STANNIC OXIDE 
Packaging
#Item CodePackage Description
1NDC:51389-106-011 CONTAINER (CONTAINER) in 1 KIT
19 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/13/2011
Labeler - LAURA GELLER MAKE UP INC. (199474524)
Establishment
NameAddressID/FEIOperations
CHROMAVIS SPA338561621manufacture

Revised: 11/2011
 
LAURA GELLER MAKE UP INC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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