Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 22413f93-7219-4726-b741-2392e576b34a
Route
TOPICAL
Published
Effective Date 2024-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (101 mg) Zinc Oxide (78 mg)
Inactive Ingredients
Allantoin Benzyl Alcohol Alkyl (c12-15) Benzoate Caffeine Caprylyl Trisiloxane Chromic Oxide Dicaprylyl Carbonate Dimethicone Glycyrrhizinate Dipotassium Ethylhexylglycerin Glycerin Hydrogenated Soybean Lecithin Ferric Oxide Red Isohexadecane Magnesium Sulfate, Unspecified Form Methylpropanediol Silicon Dioxide Tocopherol Triethoxycaprylylsilane Trisiloxane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-31

Description

Titanium Dioxide 10.1% Zinc Oxide 7.8 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 10.1% Zinc Oxide 7.8 %

Use(s)

• 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

For external use only

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes.

Rinse with water to remove.

Directions

• Apply liberally 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating

• Reapply at least every 2 hours.

• Children under 6 months: ask a doctor

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of 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 10am – 2 pm.

• Wear long-sleeved shirts, pants, hats, and sun glasses.

Questions?

1-866-735-4137

Other Information

• Protect this product from excessive heat and direct sun.

Active Ingredients

Titanium Dioxide 10.1%

Zinc Oxide 7.8 %

Inactive Ingredients

ALLANTOIN, BENZYL ALCOHOL, C12-15 ALKYL BENZOATE, CAFFEINE, CAPRYLYL METHICONE, CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY) SILYLETHYL DIMETHICONE, CHROMIUM OXIDE GREENS, DICAPRYLYL CARBONATE, DIMETHICONE, DIPOTASSIUM GLYCYRRHIZATE, ETHYLHEXYLGLYCERIN, GLYCERIN, HYDROGENATED LECITHIN, IRON OXIDES, ISOHEXADECANE, MAGNESIUM SULFAGE, MEHYLPROPANEDIOL, SILICA, TOCOPHEROL, TRIETHOXYCAPRYLYLSILANE, TRISILOXANE, WATER

Keep Out of Reach of Children.

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

Principal Display Panel 1.7 Fl Oz (50 Ml) Carton

NEW



Cetaphil®

SUN

40



Everyday Sunscreen

Tinted Face Lotion




Broad Spectrum SPF 40



All Skin Types



Hydrating formula soothes, protects

and blends seamlessly with a variety

of skin tones



100% Mineral UVA/UVB Filters &

Antioxidant Vitamin E



Tinted



Pump tube image



National Eczema Association logo



1.7 FL OZ (50 ML)

Distributed by:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their

respective owners.



cetaphil.com

P57726-0


Structured Label Content

Use(s)

• 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

For external use only

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes.

Rinse with water to remove.

Directions

• Apply liberally 15 minutes before sun exposure.

• Use a water resistant sunscreen if swimming or sweating

• Reapply at least every 2 hours.

• Children under 6 months: ask a doctor

SUN PROTECTION MEASURES: Spending time in the sun increases your risk of 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 10am – 2 pm.

• Wear long-sleeved shirts, pants, hats, and sun glasses.

Questions?

1-866-735-4137

Other Information

• Protect this product from excessive heat and direct sun.

Active Ingredients

Titanium Dioxide 10.1%

Zinc Oxide 7.8 %

Inactive Ingredients

ALLANTOIN, BENZYL ALCOHOL, C12-15 ALKYL BENZOATE, CAFFEINE, CAPRYLYL METHICONE, CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY) SILYLETHYL DIMETHICONE, CHROMIUM OXIDE GREENS, DICAPRYLYL CARBONATE, DIMETHICONE, DIPOTASSIUM GLYCYRRHIZATE, ETHYLHEXYLGLYCERIN, GLYCERIN, HYDROGENATED LECITHIN, IRON OXIDES, ISOHEXADECANE, MAGNESIUM SULFAGE, MEHYLPROPANEDIOL, SILICA, TOCOPHEROL, TRIETHOXYCAPRYLYLSILANE, TRISILOXANE, WATER

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.

Principal Display Panel 1.7 Fl Oz (50 Ml) Carton (PRINCIPAL DISPLAY PANEL - 1.7 FL OZ (50 mL) carton)

NEW



Cetaphil®

SUN

40



Everyday Sunscreen

Tinted Face Lotion




Broad Spectrum SPF 40



All Skin Types



Hydrating formula soothes, protects

and blends seamlessly with a variety

of skin tones



100% Mineral UVA/UVB Filters &

Antioxidant Vitamin E



Tinted



Pump tube image



National Eczema Association logo



1.7 FL OZ (50 ML)

Distributed by:

Galderma Laboratories, L.P.

Dallas, TX 75201 USA

All trademarks are the property of their

respective owners.



cetaphil.com

P57726-0


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