Elizabeth Arden Eight Hour Hydraplay Spf 40

Elizabeth Arden Eight Hour Hydraplay Spf 40
SPL v2
SPL
SPL Set ID 2cc74177-0f62-106e-e063-6394a90a6e28
Route
TOPICAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (3.5 g) Octocrylene (4.5 g) Octisalate (2.5 g) Avobenzone (1.5 g)
Inactive Ingredients
Sodium Dilauramidoglutamide Lysine Sorbitan Isostearate Potassium Sorbate Water Aloe Vera Leaf Fructose Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Sodium Phytate Sodium Benzoate Glycerin Pongamia Glabra Seed Oil Arachidyl Alcohol Betaine Butyloctyl Salicylate C12-15 Alkyl Benzoate Undecane 1,2-hexanediol Citric Acid Tocopherol Arachidyl Glucoside Powdered Cellulose Dunaliella Salina Pongamia Pinnata Seed Inulin Polysorbate 60 Caprylyl Glycol Glucose Soybean Oil Haematococcus Pluvialis Polyglyceryl-4 Laurate Silica Cellulose Gum Ethyl Ferulate Hydroxyacetophenone Rice Germ Polyglyceryl-3 Diisostearate Polyglyceryl-6 Laurate Tridecane Xanthan Gum Glycine Soja (soybean) Seed Behenyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

Avobenzone 3.0 % Homosalate 7.0 % Octisalate 5.0 % Octocrylene 9.0 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0 % Homosalate 7.0 % Octisalate 5.0 % Octocrylene 9.0 %

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
  • Stop use and ask doctor if rash occurs
Packaging

Directions

Directions For Sunscreen Use:

  • shake well and apply liberally 15 minutes before sun exposure and makeup application
  • reapply: at least every 2 hours even over makeup
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending timine in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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.
Active Ingredients

Avobenzone 3.0 %

Homosalate 7.0 %

Octisalate 5.0 %

Octocrylene 9.0 %

Inactive Ingredients

Aqua/Water/Eau, Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Pongamia Glabra Seed Oil, Undecane, Betaine, Silica, 1,2-Hexanediol, Aloe Barbadensis Leaf Juice, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Caprylyl Glycol, Cellulose, Cellulose Gum, Citric Acid, Dunaliella Salina Extract, Ethyl Ferulate, Fructose, Glucose, Glycine Soja (Soybean) Oil, Glycine Soja (Soybean) Seed Extract, Haematococcus Pluvialis Extract, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Inulin, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Polyglyceryl-3 Diisostearate, Polyglyceryl-4 Laurate, Polyglyceryl-6 Laurate, Polysorbate 60, Pongamia Pinnata Seed Extract, Sodium Dilauramidoglutamide Lysine, Sodium Phytate, Sorbitan Isostearate, Tocopherol, Tridecane, Xanthan Gum, Potassium Sorbate, Sodium Benzoate.


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

Sunscreen

Warnings
  • Stop use and ask doctor if rash occurs
Packaging

Directions

Directions For Sunscreen Use:

  • shake well and apply liberally 15 minutes before sun exposure and makeup application
  • reapply: at least every 2 hours even over makeup
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending timine in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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.
Active Ingredients

Avobenzone 3.0 %

Homosalate 7.0 %

Octisalate 5.0 %

Octocrylene 9.0 %

Inactive Ingredients

Aqua/Water/Eau, Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Pongamia Glabra Seed Oil, Undecane, Betaine, Silica, 1,2-Hexanediol, Aloe Barbadensis Leaf Juice, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Caprylyl Glycol, Cellulose, Cellulose Gum, Citric Acid, Dunaliella Salina Extract, Ethyl Ferulate, Fructose, Glucose, Glycine Soja (Soybean) Oil, Glycine Soja (Soybean) Seed Extract, Haematococcus Pluvialis Extract, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Inulin, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Polyglyceryl-3 Diisostearate, Polyglyceryl-4 Laurate, Polyglyceryl-6 Laurate, Polysorbate 60, Pongamia Pinnata Seed Extract, Sodium Dilauramidoglutamide Lysine, Sodium Phytate, Sorbitan Isostearate, Tocopherol, Tridecane, Xanthan Gum, Potassium Sorbate, Sodium Benzoate.


Advanced Ingredient Data


Raw Label Data

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