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Vichy Laboratoires

L'Oreal USA Products Inc

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Oxybenzone 6%

Vichy Laboratoires 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

Vichy Laboratoires 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

Vichy Laboratoires

Avobenzone Homosalate Octisalate Octocrylene Oxybenzone OIL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49967-999
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 5.31 mL
HOMOSALATE Homosalate 26.55 mL
OCTISALATE OCTISALATE 8.85 mL
OCTOCRYLENE Octocrylene 12.39 mL
OXYBENZONE OXYBENZONE 10.62 mL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49967-999-01 177 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-03-07


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