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Name:Vichy Laboratoirecapital Soleil Spf 30 Soft Sheer Sunscreen
Manufacturer:L'oreal Usa Products Inc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

VICHY LABORATOIRE CAPITAL SOLEIL SPF 30 SOFT SHEER SUNSCREEN - avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
L'Oreal USA Products Inc

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.

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Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

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

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.

Directions

  • apply liberally on face and body 15 minutes before sun exposure
  • reapply after 40 minutes of swimming or perspiring and after towel drynig
  • children under 6 months of age: ask a doctor

Inactive ingredients

water, glycerin, propanediol, alcohol denat., dimethicone, isodecyl neopentanoate, cyclopetasiloxane, PEG-100 stearate, glyceryl stearate, arachidyl alcohol, potassium cetyl phosphate, VP/eicosene copolymer, silica, behenyl alcohol, trimethylsiloxysilicate, arachidyl glucoside, polyacrylamide, xanthan gum, C13-14 isoparaffin, p-anisic acid, disodium EDTA, laureth-7, tocopherol, vitis vinfera (grape) fruit extract

image of carton


VICHY LABORATOIRE  CAPITAL SOLEIL SPF 30 SOFT SHEER SUNSCREEN
avobenzone homosalate octisalate octocrylene oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-089
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (Avobenzone) Avobenzone 4.5 mL  in 150 mL
Homosalate (Homosalate) Homosalate 7.5 mL  in 150 mL
Octisalate (Octisalate) Octisalate 7.5 mL  in 150 mL
Octocrylene (Octocrylene) Octocrylene 10.5 mL  in 150 mL
Oxybenzone (Oxybenzone) Oxybenzone 9 mL  in 150 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-089-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 150 mL in 1 TUBE This package is contained within the CARTON (49967-089-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/21/2011

Labeler - L'Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
L'Oreal USA Products Inc 185931458 manufacture

Revised: 04/2011 L'Oreal USA Products Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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