85940-307

85940-307
SPL v2
SPL
SPL Set ID 38898014-eefe-73ec-e063-6394a90a3738
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diethylamino Hydroxybenzoyl Hexyl Benzoate (3 g) Bisoctrizole (2 g) Iscotrizinol (1.2 g) Ethylhexyl Triazone (2.4 g)
Inactive Ingredients
Anhydrous Dextrose Water Xanthan Gum Tocopherol Pelargonium Graveolens Flower Oil Coco-caprylate/caprate Xylitylglucoside Butylene Glycol Propionate Polyquaternium-51 (2-methacryloyloxyethyl Phosphorylcholine/n-butyl Methacrylate; 3:7) Caprylyl Trisiloxane Docosanol Olive Oil Rosemary Oil Chamomile Flower Oil Acrylates Crosspolymer-4 Sodium Stearoyl Glutamate Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Tromethamine Ascorbic Acid Adenosine Centella Asiatica Triterpenoids Juniperus Deppeana Wood Oil Diisopropyl Sebacate Carbomer Homopolymer, Unspecified Type Anhydroxylitol Pentylene Glycol Clary Sage Oil Ethylhexylglycerin Dibutyl Adipate Abies Sibirica Leaf Oil Potato Pulp Chamaemelum Nobile Flower Oil Behenyl Acrylate Polymer Decyl Glucoside Aloe Vera Leaf Glycerin Pogostemon Cablin Leaf Oil Xylitol Polymethylsilsesquioxane (4.5 Microns) 1,2-hexanediol Propanediol Polyglyceryl-3 Methylglucose Distearate Niacinamide Clove Leaf Oil Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Tert-butyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Diethylhexyl Butamido Triazone 1.2% Bisoctrizole 2% Octyl Triazone (ethylhexyl triazone) 2.4% Diethylamino Hydroxybenzoyl Hexyl Benzoate 3%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

• 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.

Dosage and Administration

• apply evenly 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 increase 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

Description

Diethylhexyl Butamido Triazone 1.2% Bisoctrizole 2% Octyl Triazone (ethylhexyl triazone) 2.4% Diethylamino Hydroxybenzoyl Hexyl Benzoate 3%

85940

sunscreen

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Water, Dibutyl Adipate, Propanediol, Polymethylsilsesquioxane,

Diisopropyl Sebacate, Coco-Caprylate/Caprate, 1,2-Hexanediol,

Butylene Glycol, Glycerin, Caprylyl Methicone, Solanum

Tuberosum (Potato) Pulp Extract, Centella Asiatica Extract,

Olea Europaea (Olive) Fruit Oil, Abies Sibirica Oil, Rosmarinus

Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Pelargonium

Graveolens Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil,

Pogostemon Cablin Oil, Chamomilla Recutita (Matricaria) Flower

Oil, Juniperus Mexicana Oil, Anthemis Nobilis Flower Oil,

Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Pentylene

Glycol, Behenyl Alcohol, Poly C10-30 Alkyl Acrylate, Polyglyceryl-3

Methylglucose Distearate, Xylitylglucoside, Decyl Glucoside,

Anhydroxylitol, Tromethamine, Carbomer, Acrylates/C10-30 Alkyl

Acrylate Crosspolymer, Xylitol, Polyquaternium-51, Sodium Stearoyl

Glutamate, Polyacrylate Crosspolymer-6, Ethylhexylglycerin,

Glucose, Xanthan Gum, T-Butyl Alcohol, Tocopherol, Ascorbic Acid

Polypeptide

Section 55105-1

Sunscreen

Section 55106-9

Diethylhexyl Butamido Triazone 1.2%

Bisoctrizole 2%

Octyl Triazone (ethylhexyl triazone) 2.4%

Diethylamino Hydroxybenzoyl Hexyl Benzoate 3%


Structured Label Content

85940

sunscreen

Indications and Usage (34067-9)

• 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.

Dosage and Administration (34068-7)

• apply evenly 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 increase 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

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Water, Dibutyl Adipate, Propanediol, Polymethylsilsesquioxane,

Diisopropyl Sebacate, Coco-Caprylate/Caprate, 1,2-Hexanediol,

Butylene Glycol, Glycerin, Caprylyl Methicone, Solanum

Tuberosum (Potato) Pulp Extract, Centella Asiatica Extract,

Olea Europaea (Olive) Fruit Oil, Abies Sibirica Oil, Rosmarinus

Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil, Pelargonium

Graveolens Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil,

Pogostemon Cablin Oil, Chamomilla Recutita (Matricaria) Flower

Oil, Juniperus Mexicana Oil, Anthemis Nobilis Flower Oil,

Sodium Hyaluronate, Aloe Barbadensis Leaf Juice, Pentylene

Glycol, Behenyl Alcohol, Poly C10-30 Alkyl Acrylate, Polyglyceryl-3

Methylglucose Distearate, Xylitylglucoside, Decyl Glucoside,

Anhydroxylitol, Tromethamine, Carbomer, Acrylates/C10-30 Alkyl

Acrylate Crosspolymer, Xylitol, Polyquaternium-51, Sodium Stearoyl

Glutamate, Polyacrylate Crosspolymer-6, Ethylhexylglycerin,

Glucose, Xanthan Gum, T-Butyl Alcohol, Tocopherol, Ascorbic Acid

Polypeptide

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Diethylhexyl Butamido Triazone 1.2%

Bisoctrizole 2%

Octyl Triazone (ethylhexyl triazone) 2.4%

Diethylamino Hydroxybenzoyl Hexyl Benzoate 3%


Advanced Ingredient Data


Raw Label Data

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