PROTECTYL SOLEIL MOISTURIZING SUNSCREEN LOTION HIGH PROTECTION SPF 30- titanium dioxide, octinoxate and octocrylene cream

Protectyl soleil moisturizing sunscreen lotion high protection spf 30 by

Drug Labeling and Warnings

Protectyl soleil moisturizing sunscreen lotion high protection spf 30 by is a Otc medication manufactured, distributed, or labeled by Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Actives ingredients
Octinoxate 7.5%
Octocrylene 7.0%
Titanium dioxide 8.4%

PURPOSE

Purpose
Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses
Helps prevent sunburn. Higher SPF gives more sunburn protection.

WARNINGS

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 and irritation develops and lasts.

DOSAGE & ADMINISTRATION

Directions:
Apply liberally 15 to 30 minutes before sun exposure and as needed. Reapply as needed
or after towel drying, swimming, perspiring heavily or washing.

ASK DOCTOR

Children under 6 months of age: ask a 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

Protectyl Soleil

Moisturizing Sunscreen Lotion
High Protection SPF30

150 ml     5 fl.oz.

INGREDIENTS AND APPEARANCE

PROTECTYL SOLEIL MOISTURIZING SUNSCREEN LOTION HIGH PROTECTION SPF 30 
titanium dioxide, octinoxate and octocrylene cream

Product 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