Label: PROTECTYL SOLEIL MOISTURIZING SUNSCREEN LOTION HIGH PROTECTION SPF 30- titanium dioxide, octinoxate and octocrylene cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 54235-204-08 - Packager: Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated April 28, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- ASK DOCTOR
-
INACTIVE INGREDIENT
Inactive ingredients:
ACER SACCHARINUM (SUGAR MAPLE) EXTRACT - ALLANTOIN - ALUMINA - ALUMINUM STEARATE - BUTYLENE GLYCOL - BUTYLPARABEN - C12-15 ALKYL BENZOATE - CYCLOHEXASILOXANE - CYCLOPENTASILOXANE - DIMETHICONE - DIMETHICONE CROSSPOLYMER - ETHYLPARABEN - FRAGRANCE (PARFUM) - GLYCERIN - CLYCERYL STEARATE - HYDROGENATED DIMER DILINOLEYL / DIMETHYLCARBONATE COPOLYMER - HUDROXYETHYLCELLULOSE - 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 (AQUA) - XANTHAN GUM - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROTECTYL SOLEIL MOISTURIZING SUNSCREEN LOTION HIGH PROTECTION SPF 30
titanium dioxide, octinoxate and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54235-204 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.0 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 8.4 mL in 100 mL Inactive Ingredients Ingredient Name Strength ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC) ALLANTOIN (UNII: 344S277G0Z) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM STEARATE (UNII: U6XF9NP8HM) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLPARABEN (UNII: 3QPI1U3FV8) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR) MANGIFERIN (UNII: 1M84LD0UMD) METHYLPARABEN (UNII: A2I8C7HI9T) METHYLPROPANEDIOL (UNII: N8F53B3R4R) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARETH-100 (UNII: 4OH5W9UM87) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54235-204-08 150 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/01/2007 Labeler - Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher (347509127) Establishment Name Address ID/FEI Business Operations Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher 347509127 manufacture