Hydra Finish Spf 15 Cream
FDA Label NDC 54181-006

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 Finish Spf 15 (NDC 54181-006). 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

Homosalate 4.0%

Octinoxate 6.0%

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. – 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

Inactive Ingredients

Water (Aqua), Titanium Dioxide (CI 77891), Cyclopentasiloxane, Ethylhexyl Stearate, Glycerin, C14- 22 Alcohols, Cyclohexasiloxane, Diethylhexyl 2,6-Naphthalate, Hydrogenated Coco-Glycerides, Propanediol, Microcrystalline Cellulose, Glyceryl Stearate Citrate, Pentylene Glycol, Iron Oxides (CI 77492), Propylene Glycol, Polyglyceryl-3 Stearate, Mica, Acrylates/Ammonium Methacrylate Copolymer, Isopropyl Myristate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, C12-20 Alkyl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Fragrance (Parfum), Hydrogenated Lecithin, Tocopheryl Acetate, Ethylhexylglycerin, Triethyl Citrate, Hexyldecanol, Silica, Iron Oxides (CI 77499), Iron Oxides (CI 77491), Cellulose Gum, Ceteareth-20, Triethanolamine, Betaine, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Pectin, Polysorbate 60, Sorbitan Isostearate, Sucrose, Butylene Glycol, Capryloyl Glycine, Sodium Hyaluronate, Red 33 (CI 17200), Malva Sylvestris (Mallow) Extract, Pyrus Malus (Apple) Seed Extract, Brassica Campestris (Rapeseed) Sterols, Tocopherol. 01

Package Labeling:

Guinot1 (Guinot1)

Guinot1 (Guinot1)

Guinot2 (Guinot2)

Guinot2 (Guinot2)

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