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HAUTE PROTECTION High Protection Tinted Compact BROAD SPECTRUM SPF 50 HONEY

Dosage form: cream
Ingredients: TITANIUM DIOXIDE 18g in 100g, ZINC OXIDE 4.9g in 100g
Labeler: Pierre Fabre Dermo Cosmetique
NDC Code: 67015-1101

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.

HAUTE PROTECTION High Protection Tinted Compact BROAD SPECTRUM SPF 50 HONEY

Active Ingredients

TITANIUM DIOXIDE 18 %
ZINC OXIDE   4.9 %

Purpose

Sunscreen

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions) decreases the risk if skin cancer and early skin aging caused by the sun.

Warnings
  • 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.
  • Stop use and ask a doctor if rash occurs.

Keep out of reach of children

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

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.
  • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other skin protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor


Questions ?

Questions ? : 1-866-41-AVENE (USA) / 1-877-441-2011 (CAN)

Inactive Ingredients

DIMETHICONE, HYDROGENATED POLYISOBUTENE, PHENYL TRIMETHICONE ISODECYL NEOPENTANOATE, SQUALANE, POLYETHLENE, TALC, ETYLHEXYL HYDROXYSTEARATE, SILICA, POLYMETHYL, METHACRYLATE, POLYGLYCERLYL-3 DIISOSTEARATE, WATER/EAY (AQUA), BEESWAX/CIRE D'ABELLE (CERA ALBA), CAPRYLIC/CAPRIC TRIGLYCERIDE, MICROCRYSTALLINE WAX/CIRE MICROCRISTALINE (CERA MICROCRISTALLINA), PHENOXYETHANOL, TOCOPHERYL, GLUCOSIDE, TRIBEHENIN, TRIETHOXYCAPRYLYLSILIXANE, TITANIUM DIOXIDE (CI77891), IRON OXIDES (CI77491), (CI77492), (CI77499)

Other Information

Protect this product from excessive heat and direct sun.

HAUTE PROTECTION High Protection Tinted Compact BROAD SPECTRUM SPF 50 HONEY 10g (67015-1101-0)

HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 HONEY 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67015-1101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE18 g  in 100 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE4.9 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
HYDROGENATED POLYBUTENE (1300 MW) 
PHENYL TRIMETHICONE 
ISODECYL NEOPENTANOATE 
SQUALANE 
HIGH DENSITY POLYETHYLENE 
TALC 
ETHYLHEXYL HYDROXYSTEARATE 
SILICON DIOXIDE 
POLYGLYCERYL-3 DIISOSTEARATE 
WATER 
YELLOW WAX 
MEDIUM-CHAIN TRIGLYCERIDES 
MICROCRYSTALLINE WAX 
PHENOXYETHANOL 
TRIBEHENIN 
TRIETHOXYCAPRYLYLSILANE 
FERRIC OXIDE RED 
Packaging
#Item CodePackage Description
1NDC:67015-1101-010 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2011
Labeler - Pierre Fabre Dermo Cosmetique (378028104)
Registrant - Pierre Fabre Dermo Cosmetique (378028104)
Establishment
NameAddressID/FEIOperations
Tecnocosmesi S.p.A.435445218manufacture(67015-1101)

Revised: 04/2013
 
Pierre Fabre Dermo Cosmetique

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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