Drug labels

Hydra Finish SPF 15

HOMOSALATE, OCTINOXATE · Guinot · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
4047e8ec-834a-41e6-a144-5649a7718de4
ID
5b1ce64a-c6e2-52bd-e063-6394a90a3abd
Effective time
20260910
Version
11
SPL product data elements

Hydra Finish SPF 15 HOMOSALATE, OCTINOXATE HOMOSALATE HOMOSALATE OCTINOXATE OCTINOXATE WATER TITANIUM DIOXIDE CYCLOMETHICONE 5 ETHYLHEXYL STEARATE GLYCERIN C14-22 ALCOHOLS CYCLOMETHICONE 6 DIETHYLHEXYL 2,6-NAPHTHALATE HYDROGENATED COCO-GLYCERIDES PROPANEDIOL CELLULOSE, MICROCRYSTALLINE GLYCERYL STEARATE CITRATE PENTYLENE GLYCOL FERRIC OXIDE YELLOW PROPYLENE GLYCOL MICA ISOPROPYL MYRISTATE BEMOTRIZINOL C12-20 ALKYL GLUCOSIDE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) HYDROGENATED SOYBEAN LECITHIN .ALPHA.-TOCOPHEROL ACETATE ETHYLHEXYLGLYCERIN TRIETHYL CITRATE HEXYLDECANOL SILICON DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM POLYOXYL 20 CETOSTEARYL ETHER TROLAMINE BETAINE PECTIN POLYSORBATE 60 SORBITAN ISOSTEARATE SUCROSE BUTYLENE GLYCOL CAPRYLOYL GLYCINE HYALURONATE SODIUM D&C RED NO. 33 MALVA SYLVESTRIS FLOWERING TOP APPLE SEED RAPESEED STEROL TOCOPHEROL

SPL unclassified section
Drug Facts, Other information Protect this product from excessive heat and direct sun
Active ingredient
Active ingredients Homosalate 4.0% Octinoxate 6.0% purpose Sunscreen
Purpose
purpose Sunscreen
Indications and usage

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

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.

Do not use
Do not use on damaged or broken skin
When using
When using this product keep out of eyes. Rinse with water to remove
Stop use
Stop use and ask a doctor if rash occurs
Keep out of reach of children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage and administration

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

Inactive ingredient

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 label principal display panel
Package Labeling: 54181-006-30 Outer Inner
Harmonized identifiers (openFDA)
Application number
M020
Brand name
Hydra Finish SPF 15
Generic name
HOMOSALATE, OCTINOXATE
Manufacturer name
Guinot
Product NDC
54181-006
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
HOMOSALATE, OCTINOXATE
SPL ID
5b1ce64a-c6e2-52bd-e063-6394a90a3abd
SPL set ID
4047e8ec-834a-41e6-a144-5649a7718de4
Package NDC
54181-006-30
Is original packager
true
Upc
3500465068753
UNII
V06SV4M95S, 4Y5P7MUD51
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.