CETAPHIL - titanium dioxide, zinc oxide lotionGalderma Laboratories , L.P.

CETAPHIL - titanium dioxide, zinc oxide lotionGalderma Laboratories , L.P.

Drug Labeling and Warnings

Drug Details

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CETAPHIL REDNESS RELIEVING DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 20- titanium dioxide, zinc oxide cream 
Galderma Laboratories, L.P.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CETAPHIL - titanium dioxide, zinc oxide lotion
Galderma Laboratories , L.P.

Active Ingredients

Titanium Dioxide 10.1%
Zinc Oxide 7.8 %

Purpose

Titanium Dioxide ..........Sunscreen
Zinc Oxide ...................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 DEMTHICONE, 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

Cetaphil Redness Relieving SPF 20 Moisturizer Carton

Cetaphil®
REDNESS RELIEVING
Daily Facial Moisturizer
with sunscreen
BROAD SPECTRUM SPF 20
Neutral Tint

REDNESS-PRONE SKIN
Tinted formula neutralizes the appearance of redness and evens skin tone
Moisturizes and soothes irritated or sensitive skin
Non-comedogenic
Fragrance free
UVA/UVB protection
1.7 FL OZ (50 ML)

Cetaphil®
REDNESS RELIEVING
Daily Facial Moisturizer
with sunscreen
BROAD SPECTRUM SPF 20

For Redness-Prone Skin:

Moisturize to help reduce the appearance of redness due to dry skin
Tinted formula neutralizes the look of redness, evens skin tone
Mineral based sunscreen
Non-comedogenic, Fragrance free
Dermatologist developed and tested

Distributed by:
Galderma Laboratories, L.P.
Fort Worth, TX 76177 USA
Cetaphil is a registered trademark.
Made in Canada
Cetaphil.com


Cetaphil®
REDNESS RELIEVING
Daily Facial Moisturizer
with sunscreen
BROAD SPECTRUM SPF 20

This neutral tinted moisturizer hydrates the natural, protective skin barrier leaving it soothed and balanced. It is a lightweight formula with sunscreen that moisturizes dry skin to help reduce the appearance of redness due to dry skin.
For a complete skin care regimen, use Cetaphil Foaming Face Wash before application of the Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen BROAD SPECTRUM SPF 20

Actual Size
P53244-2

CETAPHIL REDNESS RELIEVING DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 20 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0299-5889
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE101 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE78 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0299-5889-001 in 1 CARTON12/09/2016
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 0299-5889-0510 mL in 1 TUBE; Type 0: Not a Combination Product12/09/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/09/2016
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIBusiness Operations
G Production Inc.251676961manufacture(0299-5889)

Revised: 9/2017
 
Galderma Laboratories, L.P.


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