Label: HYDRA VEGETAL FPS 30 SPF CREME HYDRANTE- octinoxate, avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 63505-009-02 - Packager: Yves Rocher North America Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 1, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients w/w / Ingrédients actifs p/p
- Purpose/Utilité
- Use / Usage
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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.
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Directions / Mode d'emploi
- 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.
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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.
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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
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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
- Principal Display Panel - Hydra Vegetal FPS 30 Tube Label
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INGREDIENTS AND APPEARANCE
HYDRA VEGETAL FPS 30 SPF CREME HYDRANTE
octinoxate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63505-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 g in 100 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.75 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:63505-009-02 50 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2018 Labeler - Yves Rocher North America Inc. (201826448) Registrant - Empack Spraytech Inc (252047519) Establishment Name Address ID/FEI Business Operations Empack Spraytech Inc 252047519 MANUFACTURE(63505-009)
