FDA.reportPublic FDA data

HYDRA VEGETAL FPS 30 SPF CREME HYDRANTE

Manufacturer
Yves Rocher North America Inc. | Empack Spraytech Inc
Effective date
2018-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:55:19

Label at a glance#

ProductHYDRA VEGETAL FPS 30 SPF CREME HYDRANTE
Active ingredientOCTINOXATE, Avobenzone
Label structure9 sections

Dosage and administration

Apply liberally and generously 15 minutes before sun exposure. For sunscreen use reapply: at least every 2 hours Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including...

Label contents#

Full prescribing information#

Active Ingredients w/w / Ingrédients actifs p/p

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 0.75%, Octinoxate 2.0%

Purpose/Utilité

OTC - PURPOSE SECTION

Sunscreen/Écran solaire

Use / Usage

INDICATIONS & USAGE SECTION

Helps prevent sunburn /Aide à prévenir les coups de soleil

Warnings / Mises en garde

WARNINGS SECTION

For external use only / Pour usage externe seulement

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and generously 15 minutes before sun exposure.
  • For sunscreen use
  • reapply: at least every 2 hours Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 am - 2 pm
    • wear hats, and sunglasses.
  • For use on children less than 6 months of age, consult a doctor /
  • Appliquer abondamment et généreusement 15 minutes avant l'exposition au soleil
  • Pour utilisation comme écran solaire : Appliquer de nouveau : au moins toutes les 2 heures. Utiliser un écran solaire résistant à Léau lors d`une activité aquatique ou s'il y a transpiration.
  • Mesures de protection contre le soleil : Passer du temps au soleil augmente le risque de cancer de la peau et de vieillissement prématuré de la peau. Afin de diminuer ce risque, il convient d'utiliser régulièrement un écran solaire avec un F.P.S. à large spectre d'au moins 15 et d'appliquer d'autres mesures de protection contre le soleil, telles que :
    • limiter le temps passé au soleil, notamment entre 10 et 14 heures
    • porter un chapeau et des lunettes de soleil
  • Pour les enfants âgés de moins de 6 mois, consulter un médecin.

Other Information / Autre renseignement

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun. /
  • Tenir loin de la chaleur excessive ou des rayons de soleil. /
  • Store at room temperature 15-30°C (59-86°F). /
  • Conserver à la température de la pièce entre 15-30°C (59-86°F).

Inactive Ingredients / Ingrédients inactifs

INACTIVE INGREDIENT SECTION

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.

OTC - QUESTIONS SECTION

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

Principal Display Panel - Hydra Vegetal FPS 30 Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Principal Display Panel - Hydra Vegetal FPS 30 Tube Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-133660005692845GTIN-13: 3660005692845
EAN-13: 3660005692845
GTIN storage (14 digits): 03660005692845		hyd0p-0000-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63505-009-022021-01-29C16284748780-1ba0f9c33-2d45-a910-e053-dadaa90a0b85Drug Facts / Information sur le médicament

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63505-00963505-009-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
AvobenzoneG63QQF2NOXACTIB
Aloe Vera LeafZY81Z83H0XIACT
AminomethylpropanolLU49E6626QIACT
Ammonium Acryloyldimethyltaurate/Vp CopolymerW59H9296ZGIACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Camellia Oleifera Leaf5077EL0C60IACT
Carthamus Tinctorius (Safflower) Oleosomes9S60Q72309IACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
GlycerinPDC6A3C0OXIACT
PhenoxyethanolHIE492ZZ3TIACT
Ethylhexylglycerin147D247K3PIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
Water059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
12dbf4dc-6975-4fe9-b63b-e928339110eb46e7aa19-395e-48cb-a368-031e39812b732018-06-01WarningsExact identifier
spl id: 12dbf4dc-6975-4fe9-b63b-e928339110eb
spl set id: 46e7aa19-395e-48cb-a368-031e39812b73

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.