HYDRA VEGETAL FPS 30 SPF CREME HYDRANTE- octinoxate, avobenzone lotion 
Yves Rocher North America 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 / Information sur le médicament

Active Ingredients w/w / Ingrédients actifs p/p

Avobenzone 0.75%, Octinoxate 2.0%

Purpose/Utilité

Sunscreen/Écran solaire

Use / Usage

Helps prevent sunburn /Aide à prévenir les coups de soleil

Warnings / Mises en garde

For external use only / Pour usage externe seulement

Do not use on damaged or broken skin / Ne pas utiliser sur la peau endommagée ou présentant des lésions

When using this product keep out of eyes. Rinse with water to remove. / Lorsque vous utilisez ce produit éviter tout contact avec les yeux. Rincer à l'eau le cas échéant.

Stop use ask a doctor if rash occurs / Cesser l'utilisation et consulter un médecin si une éruption cutanée apparait

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. / Garder hors de portée des enfants En cas d'ingestion, consulter un médecin immédiatement ou appeler un centre antipoison.

Directions / Mode d'emploi

Other Information / Autre renseignement

Inactive Ingredients / Ingrédients inactifs

Acrylates Copolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Ammonium Acryloyldimethyltaurate / VP Copolymer, C12-15 Alkyl Benzoate, Camellia Oleifera Leaf Extract, Carthamus Tinctorius (Safflower) Oleosomes, dl-alpha Tocopheryl Acetate, Ethylhexylglycerin, Fragrance, Glycerin, Phenoxyethanol, Phenyl Trimethicone, Water/Eau.

Questions ? Composez le / Call: USA. 1-800-321-3434 / CAN. 1-800-361-2746

Principal Display Panel - Hydra Vegetal FPS 30 Tube Label

YVES ROCHER Brand Logo

HYDRA VÉEGÉTAL

SPF 30 FPS

Crème Hydrantante/ Moisturizing Cream

FPS 30 à large spectre/ SPF 30 Broad Spectrum

Toutes peaux/All skin type

ÉCRAN SOLAIRE/ SUNSCREEN

50 ml- 1.7 fl.oz.

Principal Display Panel - Hydra Vegetal FPS 30 Tube Label
HYDRA VEGETAL FPS 30 SPF CREME HYDRANTE 
octinoxate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63505-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.75 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Aminomethylpropanol (UNII: LU49E6626Q)  
Ammonium Acryloyldimethyltaurate/Vp Copolymer (UNII: W59H9296ZG)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Camellia Oleifera Leaf (UNII: 5077EL0C60)  
Carthamus Tinctorius (Safflower) Oleosomes (UNII: 9S60Q72309)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Glycerin (UNII: PDC6A3C0OX)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63505-009-0250 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2018
Labeler - Yves Rocher North America Inc. (201826448)
Registrant - Empack Spraytech Inc (252047519)
Establishment
NameAddressID/FEIBusiness Operations
Empack Spraytech Inc252047519MANUFACTURE(63505-009)

Revised: 6/2018
Document Id: 12dbf4dc-6975-4fe9-b63b-e928339110eb
Set id: 46e7aa19-395e-48cb-a368-031e39812b73
Version: 1
Effective Time: 20180601
 
Yves Rocher North America Inc.