Protectyl Soleil Moisturizing Sunscreen SPF 30

Dosage form: lotion
Ingredients: OCTINOXATE 7.5mL in 100mL, OCTOCRYLENE 7mL in 100mL, TITANIUM DIOXIDE 8.4mL in 100mL
Labeler: Yves Rocher North America Inc
NDC Code: 63505-002

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.

Protectyl Soleil Moisturizing Sunscreen Lotion SPF 30

Protectyl Soleil Moisturizing Sunscreen Lotion SPF 30


Active Ingredients

OCTINOXATE  7.5%
OCTOCRYLENE  7%
TITANIUM DIOXIDE 8.4%

Purpose
  • Sunscreen

Uses
  • Helps prevent sunburn.

Warnings
  • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
  •  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 the product is swallowed, get medical help or contact a Poison Control Center right away.

Direction
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours and after swimming or towel drying
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months:  Ask a doctor

Inactive Ingredients

ACER SACCHARUM (SUGAR MAPLE) EXTRACT • ALLANTOIN •ALUMINA • ALUMINUM STEARATE • BUTYLENE GLYCOL • BUTYLPARABEN • C12-15 ALKYL BENZOATE • CYCLOHEXASILOXANE • CYCLOPENTASILOXANE • DIMETHICONE • DIMETHICONE CROSSPOLYMER • ETHYLPARABEN • PARFUM/FRAGRANCE • GLYCERIN • GLYCERYL STEARATE • HYDROGENATED DIMER DILINOLEYL/DIMETHYLCARBONATE COPOLYMER • HYDROXYETHYLCELLULOSE • MANGIFERIN • METHYLPARABEN •METHYLPROPANEDIOL • PEG-100 STEARATE • PHENOXYETHANOL • POLYHYDROXYSTEARIC ACID • PROPYLENE GLYCOL •PROPYLPARABEN • SILICA •SORBITAN STEARATE • STEARETH-100 • TETRASODIUM EDTA • TOCOPHERYL ACETATE • VP/EICOSENE COPOLYMER • WATER /EAU • XANTHAN GUM

Other information
  • Protect this product from excessive heat and direct sun.

YVES ROCHER   PRTECTYL soleil  SUN CARE PROTECTION Moisturizing Sunscreen Lotion  SPF 30  150 ml  5 fl. oz.   Dist. By  Yves Rocher Amerique du Nord Inc.  Longueuil - Quebec J4G 2V7   Made in France  www.yves-rocher.com   USA 1-800-321-3434    CANADA  1-800-361-2746

Protectyl Soleil Moisturizing Sunscreen Lotion SPF 30 5oz/150ml (63505-002-05)

PROTECTYL SOLEIL MOISTURIZING SUNSCREEN SPF 30 
octinoxate, octocrylene, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63505-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE7 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE8.4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACER SACCHARUM SAP 
ALLANTOIN  
ALUMINUM OXIDE 
ALUMINUM STEARATE 
BUTYLENE GLYCOL 
BUTYLPARABEN 
ALKYL (C12-15) BENZOATE 
CYCLOMETHICONE 6 
CYCLOMETHICONE 5 
DIMETHICONE 
ETHYLPARABEN 
GLYCERIN 
GLYCERYL MONOSTEARATE 
MANGIFERIN 
METHYLPARABEN 
METHYLPROPANEDIOL 
PEG-100 STEARATE 
PHENOXYETHANOL 
POLYHYDROXYSTEARIC ACID (2300 MW) 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SILICON DIOXIDE 
SORBITAN MONOSTEARATE 
STEARETH-100 
EDETATE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:63505-002-05150 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/19/2012
Labeler - Yves Rocher North America Inc (201908311)
Establishment
NameAddressID/FEIOperations
Yves Rocher North America Inc. DBA Laboratoire de Biologie vegetal Yves Rocher347509127manufacture

Revised: 06/2012
 
Yves Rocher North America 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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