La Roche-Posay Laboratoire Pharmaceutique Rosaliac UV Fortifying Anti-Redness Moisturizer SPF 15

Dosage form: lotion
Ingredients: Avobenzone 0.8mL in 40mL, Octisalate 1.32mL in 40mL, Octocrylene 1.848mL in 40mL
Labeler: Laboratoires Industriels de Vichy (LIDV)
NDC Code: 66382-542

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

Avobenzone 1.98%

Octislate 3.3%

Octocrylene 4.62

Uses Directions

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • protects from UVA/UVB rays
Directions
  • apply evenly before sun exposure and as needed
  • children under 6 months of age: ask a doctor



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.

LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ROSALIAC UV  FORTIFYING ANTI-REDNESS MOISTURIZER SPF 15
avobenzone octisalate octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66382-542
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone0.8 mL  in 40 mL
Octisalate (Octisalate) Octisalate1.32 mL  in 40 mL
Octocrylene (Octocrylene) Octocrylene1.848 mL  in 40 mL
Packaging
#Item CodePackage Description
1NDC:66382-542-011 TUBE (TUBE) in 1 CARTON
140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/2009
Labeler - Laboratoires Industriels de Vichy (LIDV) (282658798)
Establishment
NameAddressID/FEIOperations
Laboratoires Industriels de Vichy (LIDV)282658798manufacture

Revised: 02/2010
 
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 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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