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TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 02 MEDIUM

Dosage form: powder
Ingredients: OCTINOXATE 25mg in 1mL
Labeler: Guerlain S.A.
NDC Code: 49817-0064

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.

TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 02 MEDIUM

Drug Facts


Active ingredients

Octinoxate  2.5%

Purpose

Sunscreen

Uses
  • Helps prevent sunburn

Warnings
  • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to help prevent sunburn, not skin cancer or early skin aging
  • 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.  Keep away from face to avoid breathing it.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children

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

Directions

For sunscreen use:

  • Reapply at least every two hours.
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months: Ask a doctor.
  • Spray liberally and spread evenly by hand 15 minutes before sun exposure
  • Hold container 4 to 6 inches from the skin to apply
  • Do not spray directly into the face.  Spray on hands then apply to face.
  • Do not apply in windy conditions
  • Use in a well-ventilated area.

Inactive ingredients

BUTANE, AQUA (WATER), ISOBUTANE, CYCLOPENTASILOXANE, PROPANE, NYLON-12, COCOGLYCERIDES, SORBITAN ISOSTEARATE, GLYCERIN, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ALUMINUMMAGNESIUM HYDROXIDE STEARATE, PHENOXYETHANOL, SODIUM CHLORIDE, ZINC STEARATE, CAPRYLYL GLYCOL, POTASSIUM SOBRATE, SILICA, HEXYLENE GLYCOL, DIMETHICONE, PARFUM (FRAGRANCE), TOCOPHEROL, ASCORBYL PALMITATE, BENZYL SALICYLATE, LIMONENE, LINALOOL, ALPHA-ISOMETHYL IONONE, CITRONELLOL, HEXYL CINNAMAL, CINNAMYL ALCOHOL, GERANIOL, EUGENOL, [MAY CONTAIN MICA, CI77891 (TITANIUM DIOXIDE), CI 77491, CI 77492, CI 77499 (IRON OXIDES), CI 77007 (ULTRAMARINES)]

Other information

Protect this product from excessive heat and direct sun.

Question or comments?

In USA: 19 East, 57th Street, New York, NY 10022

HIGHLY INFLAMMABLE

Pressurized container.  Do not expose to sunlight or temperatures exceeding 500C / 1200F.  Do not pierce or burn, even after use.  Keep away from flames and all sources of ignition.  No smoking.  Flammable components by volume: 50%.

Product Labels

TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 02 MEDIUM 
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49817-0064
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BUTANE 
WATER 
ISOBUTANE 
CYCLOMETHICONE 5 
PROPANE 
NYLON-12 
COCO-GLYCERIDES 
SORBITAN ISOSTEARATE 
GLYCERIN 
DIMETHICONE 
PHENOXYETHANOL 
SODIUM CHLORIDE 
ZINC STEARATE 
CAPRYLYL GLYCOL 
POTASSIUM SORBATE 
SILICON DIOXIDE 
HEXYLENE GLYCOL 
TOCOPHEROL 
ASCORBYL PALMITATE 
BENZYL SALICYLATE 
LINALOOL, (+/-)- 
ISOMETHYL-.ALPHA.-IONONE 
.BETA.-CITRONELLOL, (R)- 
.ALPHA.-HEXYLCINNAMALDEHYDE 
CINNAMYL ALCOHOL 
GERANIOL 
EUGENOL 
MICA 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
ULTRAMARINE BLUE 
Packaging
#Item CodePackage Description
1NDC:49817-0064-11 BOTTLE (BOTTLE) in 1 CARTON
175 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/10/2014
Labeler - Guerlain S.A. (395158322)
Establishment
NameAddressID/FEIOperations
Intercos Europe Spa338578473manufacture(49817-0064)

Revised: 04/2014
 
Guerlain S.A.

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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