Hydra Beaute Spf 15 Cream
FDA Label NDC 54181-009

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guinot for the product Hydra Beaute Spf 15 (NDC 54181-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 2.85%

Homosalate 5.00%

Octinoxate 7.00%

Octisalate 3.00%

Octocrylene 9.00%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

  • For external use only.

Do Not Use

on damaged or broken skin.

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

if rash occurs.

Keep Out Of Reach Of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • 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 of 15 or higher and other sun protection measures including:

    • - Limit time in the sun, especially from 10 a.m. to 2 p.m.

    - Wear long-sleeve shirts, pants hats, and sunglasses.

    • Children under 6 months: Ask a doctor.

Other Information

  • Protect this product from excessive heat and direct sun.
  • Store below 30°C/86°F.

Inactive Ingredients

Water/Eau (Aqua), Glycerin, Cetyl Alcohol, Caprylic/Capric Triglyceride, Pentylene Glycol, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polymethylsilsesquioxane, Caprylyl Methicone, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogenated Lecithin, Palmitic Acid, Propylene Glycol, Ethylhexylglycerin, Bisabolol, Oxidized Corn Oil, Tocopheryl Acetate, Stearalkonium Hectorite, Fragrance (Parfum), Xanthan Gum, C30-45 Alkyl Cetearyl Diemthicone Crossspolymer, Betaine, Propylene Carbonate, Polysorbate 60, Sorbitan Isostearate, Disodium EDTA, Laminaria Ochroleuca Extract, Pectin, Butylene Glycol, Sucrose, Glyceryl Acrylate/Acrylic Acid Copolymer, Capryloyl Glycine, Sodium Hyaluronate, Red 4 (CI 14700). 01

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