PROTECTYL SOLEIL MOISTURIZING SUNSCREEN LOTION HIGH PROTECTION SPF 30 - titanium dioxide, octinoxate and octocrylene cream
Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher

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

Purpose
Sunscreen

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

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

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.

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.

Children under 6 months of age: ask a doctor.

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

Protectyl Soleil

Moisturizing Sunscreen Lotion
High Protection SPF30

150 ml 5 fl.oz.

Front label

Back label

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54235-204-08	150 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	05/01/2007

Labeler - Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher (347509127)

Name	Address	ID/FEI	Business Operations
Establishment
Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher		347509127	manufacture