Aqua Protection Sunscreen Broad Spectrum Spf50+

Aqua Protection Sunscreen Broad Spectrum Spf50+
SPL v8
SPL
SPL Set ID 627e6ea5-016b-4ab6-a50c-aa9c27e5cca1
Route
TOPICAL
Published
Effective Date 2025-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (90 mg) Octisalate (45 mg) Octocrylene (50 mg)
Inactive Ingredients
Water Dipropylene Glycol Propylene Glycol Butyloctyl Salicylate Polyoxyl 20 Cetostearyl Ether Ethylhexyl Methoxycrylene Polysorbate 60 Sorbitan Stearate Caprylyl Glycol Cetearyl Olivate Panthenol Sorbitan Olivate Ethylhexylglycerin Tromethamine 1,2-hexanediol Isohexadecane Ammonium Acryloyldimethyltaurate/vp Copolymer Rosa X Damascena Flower Oil Pear Butylated Hydroxytoluene Plum Polysorbate 80 Muskmelon Trisodium Ethylenediamine Disuccinate Hedera Helix Top Xanthan Gum Butylene Glycol Equisetum Arvense Branch Hyaluronate Sodium Hyaluronic Acid Betula Pendula Subsp. Mandshurica Resin Pentylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01

Description

Avobenzone, 3.0% Homosalate 9.0% Octisalate 4.5% Octocrylene, 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone, 3.0% Homosalate 9.0% Octisalate 4.5% Octocrylene, 5.0%

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 to all exposed skin 15 minutes before sun exposure.
  • Reapply at least evey 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating:
  • Children under 6 months of age: Ask a doctor.
  • Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.
Drug Facts

Do Not Use 

on damaged or broken skin.

Othe Information

Protect the product in this container from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone, 3.0%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene, 5.0%

Inactive Ingredients

Water (Aqua), Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Glyceryl Polymethacrylate, Propylene Glycol, Butyloctyl Salicylate, Ceteareth-20, Ethylhexyl Methoxycrylene, Acrylates Copolymer, Polysorbate 60, Sorbitan Stearate, Caprylyl Glycol, Cetearyl Olivate, Panthenol, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tromethamine, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, 1,2-Hexanediol, Isohexadecane, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Musa Sapientum Flower Extract, Rosa Damascena Flower Water, Pyrus Communis (Pear) Fruit Extract, Bht, Prunus Domestica Fruit Extract, Polysorbate 80, Cucumis Melo (Melon) Fruit Extract, Trisodium Ethylenediamine Disuccinate, Hedera Helix (Ivy) Leaf/Stem Extract, Xanthan Gum, Butylene Glycol, Glucosylrutin, Equisetum Arvense Extract, Lycopodium Clavatum Extract, Sodium Hyaluronate, Polyglutamic Acid, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Betula Platyphylla Japonica Juice, Pentylene Glycol

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

ir rash occurs.

Keep Out of Reach of Children.

If 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 to all exposed skin 15 minutes before sun exposure.
  • Reapply at least evey 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating:
  • Children under 6 months of age: Ask a doctor.
  • Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.
Drug Facts

Do Not Use  (Do not use )

on damaged or broken skin.

Othe Information (Othe information)

Protect the product in this container from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone, 3.0%

Homosalate 9.0%

Octisalate 4.5%

Octocrylene, 5.0%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Glyceryl Polymethacrylate, Propylene Glycol, Butyloctyl Salicylate, Ceteareth-20, Ethylhexyl Methoxycrylene, Acrylates Copolymer, Polysorbate 60, Sorbitan Stearate, Caprylyl Glycol, Cetearyl Olivate, Panthenol, Sorbitan Olivate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexylglycerin, Tromethamine, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, 1,2-Hexanediol, Isohexadecane, Ammonium Acryloyldimethyltaurate/Vp Copolymer, Musa Sapientum Flower Extract, Rosa Damascena Flower Water, Pyrus Communis (Pear) Fruit Extract, Bht, Prunus Domestica Fruit Extract, Polysorbate 80, Cucumis Melo (Melon) Fruit Extract, Trisodium Ethylenediamine Disuccinate, Hedera Helix (Ivy) Leaf/Stem Extract, Xanthan Gum, Butylene Glycol, Glucosylrutin, Equisetum Arvense Extract, Lycopodium Clavatum Extract, Sodium Hyaluronate, Polyglutamic Acid, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Betula Platyphylla Japonica Juice, Pentylene Glycol

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)

ir rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


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Raw Label Data

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