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La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with Sunscreen

Dosage form: lotion
Ingredients: Avobenzone 1.2mL in 40mL, Homosalate 4mL in 40mL, Octisalate 2mL in 40mL, Octocrylene 2mL in 40mL, Oxybenzone 2.4mL in 40mL
Labeler: L'Oreal USA Products Inc
NDC Code: 49967-095

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 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Uses
  • helps prevent sunburn
  • if used as directed (see Directions), decreases the risk of 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply generously 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 value of 15 of higher and other sun 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 of age: Ask a doctor

Purpose

Sunscreen

Other information
  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

dimethicone, C12-15 alkyl benzoate, talc, diisopropyl sebacate, silica, silica silylate, glycerin, trimethylsiloxysilicate, dimethicone crosspolymer, water, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin

Questions or comments?

1-888-LRP-LABO  1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE  ANTHELIOS 50 DAILY ANTIAGING PRIMER WITH SUNSCREEN
avobenzone homosalate octisalate octocrylene oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-095
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone1.2 mL  in 40 mL
Homosalate (Homosalate) Homosalate4 mL  in 40 mL
Octisalate (Octisalate) Octisalate2 mL  in 40 mL
Octocrylene (Octocrylene) Octocrylene2 mL  in 40 mL
Oxybenzone (Oxybenzone) Oxybenzone2.4 mL  in 40 mL
Packaging
#Item CodePackage Description
1NDC:49967-095-011 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 finalpart35204/05/2012
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIOperations
L'Oreal USA Products Inc185931458manufacture

Revised: 03/2012
Document Id: d3d5987d-1f4d-4ee5-b142-5cfa0310d21d
Set id: 6b65d6d9-7ff3-4c84-986e-ef180161eadb
Version: 1
Effective Time: 20120316
 
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 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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