Hydra Finish Spf 15

Hydra Finish Spf 15
SPL v10
SPL
SPL Set ID 4047e8ec-834a-41e6-a144-5649a7718de4
Route
TOPICAL
Published
Effective Date 2024-03-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (40 mg) Octinoxate (60 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-07-22

Description

Homosalate 4.0% Octinoxate 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 4.0% Octinoxate 6.0%

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
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
Do Not Use

on damaged or broken skin

Drug Facts

Other Information
  • Protect this product from excessive heat and direct sun
Active Ingredients

Homosalate 4.0%

Octinoxate 6.0%

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

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.

Package Labeling: 54181 006 30


Structured Label Content

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
Purpose (purpose)

Sunscreen

Warnings
  • For external use only
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
Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Other Information (Other information)
  • Protect this product from excessive heat and direct sun
Active Ingredients (Active ingredients)

Homosalate 4.0%

Octinoxate 6.0%

Inactive Ingredients (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

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor (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.

Package Labeling: 54181 006 30 (Package Labeling: 54181-006-30)


Advanced Ingredient Data


Raw Label Data

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