Extreme Protect Spf 40

Extreme Protect Spf 40
SPL v4
SPL
SPL Set ID b69db78b-5f0e-8ca2-e053-2a95a90ac88c
Route
TOPICAL
Published
Effective Date 2021-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (1.3 g) Zinc Oxide (15.3 g)
Inactive Ingredients
Ethylhexylglycerin Aloe Vera Leaf Polyurethane-34 (40 Mpa, Tensile Strength Of Film At Break) Water Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Xanthan Gum Phenoxyethanol Isostearic Acid Edetate Disodium Ferric Oxide Red Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600 Kd) Glycerin Magnesium Aluminum Silicate Oleyl Alcohol Madecassic Acid Dimethicone 100 Ferric Oxide Yellow Capryloyl Glycerin/sebacic Acid Copolymer (2000 Mpa.s) Ferrosoferric Oxide Panthenol Triacetate, (+)- Ethyl Linoleate Asiaticoside Alkyl (c12-15) Benzoate Medium-chain Triglycerides Tocopherol Sorbitan Monostearate Hexyl Laurate Butylene Glycol Pentylene Glycol Polyglyceryl-4 Isostearate Aluminum Stearate Aluminum Oxide Trideceth-6 Propylene Glycol Asiatic Acid Tribehenin Olea Europaea Leaf Polyhydroxystearic Acid (2300 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01
Description

Zinc Oxide: 15.3% Titanium Dioxide: 1.3%

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 liberally 15 minutes before sun exposure.

Reapply:

After 40 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours

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 value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10am - 2pm.

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

Description

Zinc Oxide: 15.3% Titanium Dioxide: 1.3%

Section 50565-1

Keep out of reach of children. If product is 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/Aqua/Eau, Zinc Oxide, C12-15 Alkyl Benzoate, Glycerin, Caprylic Capric Triglycerides, Tocopherol, Sorbitan Stearate, Panthenyl Triacetate, Titanium Dioxide, Pentylene Glycol, Ethyl Linoleate, Polyhydroxystearic Acid, Tribehenin, Polyurethane-62, Ethylhexylglycerin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Oleyl Alcohol, Xanthan Gum, Aluminum Stearate, Propylene Glycol, Asiaticoside, Asiatic Acid, Madecassic Acid, Alumina, Olea Europaea (Olive) Leaf Extract, Sorbitol/Sebacic Acid Copolymer Behenate, Magnesium Aluminum Silicate, Trideceth-6, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Isostearic Acid, Disodium EDTA, Polyquaternium-7, +/- CI 77491, CI 77492, CI 77499 *May contain one or more of these ingredients

Section 51945-4

Section 53413-1

Call Customer Care at (888) 804 - 4447

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide: 15.3%

Titanium Dioxide: 1.3%

Section 60561-8

Protect this product from excessive heat and direct sun.

Structured Label Content

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 liberally 15 minutes before sun exposure.

Reapply:

After 40 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours

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 value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10am - 2pm.

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

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is 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/Aqua/Eau, Zinc Oxide, C12-15 Alkyl Benzoate, Glycerin, Caprylic Capric Triglycerides, Tocopherol, Sorbitan Stearate, Panthenyl Triacetate, Titanium Dioxide, Pentylene Glycol, Ethyl Linoleate, Polyhydroxystearic Acid, Tribehenin, Polyurethane-62, Ethylhexylglycerin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Oleyl Alcohol, Xanthan Gum, Aluminum Stearate, Propylene Glycol, Asiaticoside, Asiatic Acid, Madecassic Acid, Alumina, Olea Europaea (Olive) Leaf Extract, Sorbitol/Sebacic Acid Copolymer Behenate, Magnesium Aluminum Silicate, Trideceth-6, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Isostearic Acid, Disodium EDTA, Polyquaternium-7, +/- CI 77491, CI 77492, CI 77499 *May contain one or more of these ingredients

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call Customer Care at (888) 804 - 4447

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide: 15.3%

Titanium Dioxide: 1.3%

Section 60561-8 (60561-8)

Protect this product from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.176874 · Updated: 2026-03-14T23:06:55.199519