Vichy Laboratoires Capital Soleil 30 Sunscreen Luxurious Protective

Dosage form: oil
Ingredients: Avobenzone 5.31mL in 177mL, Homosalate 26.55mL in 177mL, Octisalate 8.85mL in 177mL, Octocrylene 12.39mL in 177mL, Oxybenzone 10.62mL in 177mL
Labeler: L'Oreal USA Products Inc
NDC Code: 49967-999

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 15%

Octisalate 5%

Octocrylene 7%

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

Caution. Flammable until dry. Do not use near fire, flame, or heat.

Do not use on damaged or broken skin

When using this product

  • keep out of eyes. Rinse with water to remove.
  • keep away from face to avoid breathing it.

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
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands, then apply to face.
  • do not use in windy conditions
  • use in a well-ventilated area
  • 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
  • store at 68 - 88F (20 - 25C)

Inactive ingredients

caprylic/capric triglyceride, octyldodecanol, c12-15 alkyl benzoate, alcohol denat. ethylenediamine/stearyl dimer dilinoleate copolymer, fragrance, tocopherol, vitis vinifera (grape) seed oil, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate

Questions or comments?

Call toll free 1-877-37-VICHY Monday - Friday (9 a.m. - 5 p.m. EST)

VICHY LABORATOIRES  CAPITAL SOLEIL 30 SUNSCREEN LUXURIOUS PROTECTIVE
avobenzone homosalate octisalate octocrylene oxybenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-999
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone5.31 mL  in 177 mL
Homosalate (Homosalate) Homosalate26.55 mL  in 177 mL
Octisalate (Octisalate) Octisalate8.85 mL  in 177 mL
Octocrylene (Octocrylene) Octocrylene12.39 mL  in 177 mL
Oxybenzone (Oxybenzone) Oxybenzone10.62 mL  in 177 mL
Packaging
#Item CodePackage Description
1NDC:49967-999-01177 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/07/2012
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIOperations
L'Oreal USA Products Inc185931458manufacture

Revised: 03/2012
 
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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