Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 45d101be-2b88-4759-9ccc-556f5ec0553d
Route
TOPICAL
Published
Effective Date 2025-11-24
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 2023-07-20 Until 2025-11-05

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

Cetaphil®

SKIN REDNESS

REDNESS RELIEVING



Daily Facial 

Tinted

Moisturizer

40 BROAD SPECTRUM

     SPF 40 (UVA/UVB)

     SUNSCREEN





Tinted formula soothes

and neutralizes the

appearance of redness



Allantoin, Vitamin E

& Glycerin



AM



DERMATOLOGIST

SENSITIVE SKIN

RECOMMENDED



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

P57730-1


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)

Cetaphil®

SKIN REDNESS

REDNESS RELIEVING



Daily Facial 

Tinted

Moisturizer

40 BROAD SPECTRUM

     SPF 40 (UVA/UVB)

     SUNSCREEN





Tinted formula soothes

and neutralizes the

appearance of redness



Allantoin, Vitamin E

& Glycerin



AM



DERMATOLOGIST

SENSITIVE SKIN

RECOMMENDED



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

P57730-1


Advanced Ingredient Data


Raw Label Data

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