Hydra Beaute Cream Spf 15

Hydra Beaute Cream Spf 15
SPL v5
SPL
SPL Set ID 806d1e18-a3fc-43df-a52a-a640902d0887
Route
TOPICAL
Published
Effective Date 2018-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (28.5 mg) Homosalate (50 mg) Octinoxate (70 mg) Octisalate (30 mg) Octocrylene (90 mg)
Inactive Ingredients
Sodium Stearoyl Glutamate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Polymethylsilsesquioxane (4.5 Microns) Caprylyl Trisiloxane Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Hydrogenated Soybean Lecithin Palmitic Acid Propylene Glycol Ethylhexylglycerin Levomenol Stearalkonium Hectorite Xanthan Gum Betaine Propylene Carbonate Polysorbate 60 Sorbitan Isostearate Edetate Disodium Anhydrous Pectin Butylene Glycol Sucrose Capryloyl Glycine Hyaluronate Sodium Fd&c Red No. 4 Water Glycerin Cetyl Alcohol Medium-chain Triglycerides Pentylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-01
Description

Avobenzone 2.85% Homosalate 5.00% Octinoxate 7.00% Octisalate 3.00% Octocrylene 9.00%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.85% Homosalate 5.00% Octinoxate 7.00% Octisalate 3.00% Octocrylene 9.00%

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
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.
  • 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: Sun Protection Measures:
  • Children under 6 months: Ask a doctor.

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

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

Do Not Use

on damaged or broken skin.

Other Information
  • Protect this product from excessive heat and direct sun.
  • Store below 30°C/86°F.
Package Labeling:

Active Ingredients

Avobenzone 2.85%

Homosalate 5.00%

Octinoxate 7.00%

Octisalate 3.00%

Octocrylene 9.00%

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

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.

Structured Label Content

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
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.
  • 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: Sun Protection Measures:
  • Children under 6 months: Ask a doctor.

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

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

Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
  • Store below 30°C/86°F.
Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 2.85%

Homosalate 5.00%

Octinoxate 7.00%

Octisalate 3.00%

Octocrylene 9.00%

Inactive Ingredients (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

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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:27.195621 · Updated: 2026-03-14T23:12:39.597935