CETAPHIL SUN TINTED FACE SPF 40- titanium dioxide, zinc oxide lotion

Cetaphil Sun Tinted Face SPF 40 by

Drug Labeling and Warnings

Cetaphil Sun Tinted Face SPF 40 by is a Otc medication manufactured, distributed, or labeled by Galderma Laboratories, L.P., Knowlton Development Corporation Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 10.1%
Zinc Oxide 7.8 %

Purpose

Sunscreen

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.

Keep out of reach of children.

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

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.

Other Information

​ Protect this product from excessive heat and direct sun.

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

Questions?

1-866-735-4137

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

INGREDIENTS AND APPEARANCE

CETAPHIL SUN TINTED FACE SPF 40 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0299-4145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	101 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	78 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CHROMIC OXIDE (UNII: X5Z09SU859)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOHEXADECANE (UNII: 918X1OUF1E)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRISILOXANE (UNII: 9G1ZW13R0G)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0299-4145-00	1 in 1 CARTON	10/31/2024
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/31/2024

Labeler - Galderma Laboratories, L.P. (047350186)

Establishment
Name	Address	ID/FEI	Business Operations
Knowlton Development Corporation Inc.		204006464	manufacture(0299-4145)