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Cetaphil Daily Facial Moisturizer with suncreen SPF 50

Dosage form: lotion
Ingredients: OCTINOXATE 75mg in 1mL, OCTISALATE 50mg in 1mL, OCTOCRYLENE 70mg in 1mL, OXYBENZONE 60mg in 1mL, TITANIUM DIOXIDE 57mg in 1mL
Labeler: Galderma Laboratories, L.P.
NDC Code: 0299-4930

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.

Cetaphil Daily Facial Moisturizer with suncreen SPF 50+

Active Ingredients.....Purpose

Octinoxate 7.5% .................Sunscreen
Octisalate 5% .....................Sunscreen
Octocrylene 7% ..................Sunscreen
Oxybenzone 6% .................Sunscreen
Titanium Dioxide 5.7% ........Sunscreen

Uses

Helps prevent sunburn.

Warnings


Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early aging. This product has been shown to help prevent sunburn, not skin cancer or early aging.

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.

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Dimethicone, VP/Eicosene Copolymer, Cyclomethicone, Stearic Acid, Dimethiconol, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, Aluminum Hydroxide, Disodium EDTA, Tocopherol, Triethanolamine, Phenoxyethanol, Ethylparaben, Chlorphenesin, Cetyl Alcohol, Carbomer, Methylparaben, Xanthan Gum

Other Information

• Protect this product from excessive heat and direct sun.

Questions?

1-866-735-4137

Package Labels

Cetaphil®

Daily Facial

Moisturizer

with sunscreen

SPF 50+

Face All skin types

Non-comedogenic

Non-irritating

Fragrance free

1.7 FL OZ (50 mL)

Cetaphil

Daily Facial

Moisturizer

with sunscreen

SPF 50+

For all skin types

This clinically proven facial moisturizer nourishes and hydrates your skin while helping to defend against sunburn.

All day moisturizer leaves skin feeling soft and smooth

Non-comedogenic

Non-irritating

Fragrance free

Actual Size

Cetaphil

Daily Facial

Moisturizer

with sunscreen

SPF 50+

For all skin types

Use in combination with a complete regimen of Cetaphil cleansers and moisturizers for your daily skin care needs.

To find out more about Cetaphil products, visit cetaphil.com

Distributed by:

Galderma Laboratories, L.P.

Fort Worth, Texas 76177 USA

CETAPHIL is a registered trademark of GALDERMA

Made in Canada

cetaphil.com

P51425-4

CETAPHIL DAILY FACIAL MOISTURIZER WITH SUNCREEN SPF 50 
octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0299-4930
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE70 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE60 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE57 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
GLYCERIN 
DIMETHICONE 
VINYLPYRROLIDONE/EICOSENE COPOLYMER 
CYCLOMETHICONE 
STEARIC ACID 
DIMETHICONOL (40 CST) 
POTASSIUM CETYL PHOSPHATE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
ALUMINUM HYDROXIDE 
EDETATE DISODIUM 
TOCOPHEROL 
TROLAMINE 
PHENOXYETHANOL 
ETHYLPARABEN 
CHLORPHENESIN 
CETYL ALCOHOL 
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
METHYLPARABEN 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:0299-4930-021 TUBE in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2012
Labeler - Galderma Laboratories, L.P. (047350186)
Establishment
NameAddressID/FEIOperations
G Production Inc.251676961manufacture(0299-4930)

Revised: 02/2016
 
Galderma Laboratories, L.P.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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