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Vichy Laboratoires Normaderm Pro Mat Ultra Mattifying Oil-Free Lotion SPF 15

Dosage form: lotion
Ingredients: Ensulizole 0.54mL in 30mL, Octinoxate 2.25mL in 30mL
Labeler: Laboratoires Industriels de Vichy (LIDV)
NDC Code: 66382-446

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

Ensulizole 1.8%

Octinoxate 7.5%

Uses Directions

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
Directions
  • apply evenly before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • use on face, neck, decolletage and hands daily morning, alone or under make-up
  • smooth on gently until thoroughly absorbed

Warnings

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

Keep out of reach of children.

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

VICHY LABORATOIRES NORMADERM PRO MAT  ULTRA MATTIFYING OIL-FREE LOTION SPF 15
ensulizole octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66382-446
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (Ensulizole) Ensulizole0.54 mL  in 30 mL
Octinoxate (Octinoxate) Octinoxate2.25 mL  in 30 mL
Packaging
#Item CodePackage Description
1NDC:66382-446-011 TUBE (TUBE) in 1 CARTON
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/27/2009
Labeler - Laboratoires Industriels de Vichy (LIDV) (282658798)
Establishment
NameAddressID/FEIOperations
Laboratoires Industriels de Vichy (LIDV)282658798manufacture

Revised: 02/2010
Document Id: 393aaeea-bbc8-4ceb-91cd-e441b856876f
Set id: 168f9eee-8482-4b54-bdce-e16837c1a2ca
Version: 3
Effective Time: 20100209
 
Laboratoires Industriels de Vichy (LIDV)

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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