La Roche-Posay Laboratoire Pharmaceutique Anthelios 60 Melt-In Sunscreen Milk SPF 60

Dosage form: lotion
Ingredients: Avobenzone 4.5mL in 150mL, Homosalate 22.5mL in 150mL, Octisalate 7.5mL in 150mL, Octocrylene 7.5mL in 150mL, Oxybenzone 9mL in 150mL
Labeler: L'Oreal USA Products Inc
NDC Code: 49967-032

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

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 40 minutes of activity in the water or perspiring
  • provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin
Directions
  • apply evenly before sun exposure
  • reapply as needed or after towel drying, swimming, or perspiring
  • children under 6 months of age: ask a doctor

LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ANTHELIOS 60  MELT-IN SUNSCREEN MILK SPF 60
avobenzone homosalate octisalate octocrylene oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-032
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone4.5 mL  in 150 mL
Homosalate (Homosalate) Homosalate22.5 mL  in 150 mL
Octisalate (Octisalate) Octisalate7.5 mL  in 150 mL
Octocrylene (Octocrylene) Octocrylene7.5 mL  in 150 mL
Oxybenzone (Oxybenzone) Oxybenzone9 mL  in 150 mL
Packaging
#Item CodePackage Description
1NDC:49967-032-011 TUBE (TUBE) in 1 CARTON
1150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2009
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIOperations
L'Oreal USA Products Inc185931458manufacture

Revised: 01/2010
 
L'Oreal USA Products 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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